HospitalInspections.org

Based on observation and interview, the facility failed to provide access to suction, for use in an emergency, at the off-site primary care clinic. This failure could result in ineffective airway management during medical emergencies.

Findings:

During a tour, on 6/20/12 at 1:50 p.m., of the primary care clinic operated by the facility under the same license, emergency equipment was stored in two suitcases under the counter top in the "lab room". An Ambu bag, used for emergency breathing, hung on the wall of the room. An automated external defibrillator, (AED), used to apply electric shock in the case of cardiac arrest, was stored in a cupboard with a large sign that indicated its location. Asked about a suction machine, Manager Q stated there was no suction apparatus in the facility.

Suctioning is a way of removing foreign matter, such as vomitus, blood, or secretions from a patient's upper airway, (the mouth and throat). Effective airway management, (breathing), is dependent on an open airway to assure adequate oxygenation and survival. Ventilation of a patient, (with an Ambu bag or other device), without removing fluids may cause a patient to aspirate the fluids into the lungs which increases the risk of pneumonia, choking and hypoxia, (inadequate oxygen). www.ncbi.nlm.nih.gov/pubmed/9171541.

Based on observation, interview, and review of facility records, the facility failed to monitor and maintain recommended humidity levels in the two operating rooms, and failed to monitor air exchanges in the perioperative areas, including the operating rooms, with the potential for growth of bacterial contaminants resulting in potential increase in the risk of infection.

Findings:

During a tour, on 6/20/12 at 9:35 a.m., of the facility perioperative suite, a humidity gauge hung on the wall of Operating Room 2 beside the entrance door. The humidity read 68%.

During review, of the Operating Room Temperature Log, and concurrent interview on 6/20/12, the Director of Perioperative Services stated that the facility did not monitor humidity levels in the operating rooms.

During an interview, on 6/21/12 at 1:55 p.m., the Director of Perioperative Services stated that it was his understanding that the operating rooms had an air exchange rate of "25 to 30 air exchanges per hour", however he did not have documentation of the air exchange rate. The Director of Perioperative Services stated the Facility Manager would have the necessary documentation.

During an interview, on 6/21/12 at 10:45 a.m., Maintenance Tech L stated that balances of the air exchange had been done about three years previously, however the report was missing.

During an interview, on 6/21/12 at 3 p.m., Facility Manager D stated he could find no evidence of maintenance of the air exchange equipment and he did not know when the equipment had last been checked.

Review, on 6/27/12 at 9:30 a.m., of Recommended Practices for a Safe Environment of Care, Perioperative Standards and Recommendations, published by the Association of periOperating Room Nurses, (AORN), 2012, indicated Recommendation V.b. included: "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating room...High humidity increases the risk of microbicidal growth in areas where sterile supplies are stored or procedures performed."

Recommendation V included; "The air exchanges in the perioperative are should be carefully controlled... air in the perioperative environment can contain microbial laden dust, lint, skin flakes and respiratory droplets. Properly functioning air exchanges remove contaminants from the air and away from the sterile field. ...The minimum rate of total air exchanges per hour should be maintained at a constant level as follows. Operating Room: minimum rate of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges".

Based on interview and record review, the facility failed to ensure the safety of patients during non-medical emergencies when the Emergency Department (ED) did not have sources of lighting in the event of loss of electrical power and failure of the emergency generator. This failure had potential to adversely affect the safety and well-being of patients during emergency situations.

Findings:

During interview on 6/21/12 at 11 a.m., Facility Manager D stated in the event of loss of electrical power, the Emergency Department (ED) was connected to the hospital's emergency generator and would receive power to corridor and room lights and to all red outlets.

During concurrent observation and interview on 6/21/12 at 1:30 p.m., Registered Nurse (RN) E was asked what the ED staff would do if electrical power and emergency generator power both failed. RN E stated she had not ever experienced a failure of the emergency generator, but would use flashlights if that occurred. RN E and two other ED staff attempted to locate flashlights, and found one working flashlight, located at the nurses station.

During subsequent concurrent observation and interview on 6/21/12 at 3 p.m., Facility Manager D confirmed the ED did not have emergency battery-powered hall lights, and should have a supply of flashlights in the event of failure of the emergency generator.

The facility's policy and procedure, Number 7.03 and titled, "Loss of Electrical Power" revised 11/10, indicated the following: "4. Back-up mechanisms and reserves for loss of external power: . . . d. Uninterrupted power source (battery)".

Based on document review, interview of the Chair of the Board, interview of the Chief Executive Officer, interview of the Pharmacist in Charge, and interview of staff pharmacists, the Governing Board failed to ensure that there was a process that ensured that dosing protocols carried out by pharmacists for the antibiotic vancomycin (can have toxic effects on the kidney), the antibiotic class called aminoglycosides (include gentamicin and tobramycin: drugs which have a narrow therapeutic range and which can have toxicity for the ear and the kidney), and warfarin (an anticoagulant which reduces the ability of the blood to clot and is used to treat blood clots in the body but which also carries a risk of causing bleeding) had been brought to the attention of the Board to ensure such protocols had been approved by the organized medical staff through the auspices of the Pharmacy and Therapeutics Committee (responsible for all aspects of the pharmaceutical services in the hospital) in accordance with the Medical Staff Bylaws and consistent with State Law to ensure that provision of care via these protocols optimized patient care and ensured patient safety.

Findings:

1. California Business and Profession Code, Section 4052.1 allows a pharmacist, in a licensed health care facility (such as a hospital) to order drug therapy related laboratory tests and to initiate or adjust the drug regimen of a patient pursuant to a prescriber's order. However, this must be done in accordance with the policies, procedures, or protocols of the licensed health care facility and only after the pharmacist has received appropriate training as described in the aforementioned policies and procedures.

On 6/18/12 a review of Patient 1's clinical record indicated it contained telephone order from a physician for ceftazidime (an antibiotic) 1 gram (gm) intravenously (IV) every 8 hours "then per pharmacy staff" and "Vanco" (vancomycin: an antibiotic) "as per pharmacy." The nurse wrote the telephone order at 5:53 p.m. on 6/16/12.

At 6:30 p.m. a nurse staff member wrote a verbal order for ceftazidime 1 gm IV every 12 hours and indicated this was a renally adjusted dose to be re-evaluated and adjusted the following morning after the morning laboratory blood chemistry results were available. The nurse documented the Pharmacist in Charge (PIC) as the source of the order.

On 6/17/12 at 9:44 a.m. the PIC wrote an order to change the Ceftazidime back to 1 gm IV every 8 hours and to administer vancomycin 1500 mg IV every 24 hours. The PIC also ordered staff to draw a vancomycin trough level prior to the 6/19/12 dose. The PIC's order indicated that this was being done per physician request.

On 6/18/12 a review of Policy and Procedure 14-02 entitled PHARMACOKINETIC DOSING SERVICE (Effective date 6/92, Reviewed 10/11, no revision date available) indicated the policy of the hospital was as follows: "The pharmacy shall provide a pharmacokinetic dosing service to assist the medical staff in dosing and monitoring patients in order to minimize toxic side effect and to reduce overall facility stay costs by giving therapeutically efficacious doses." Under procedures it stipulated that: "The medical staff, through its pharmacy and therapeutics function, shall select drugs, for example, aminoglycosides, vancomycin, ... for the pharmacokinetic dosing service." It also stipulated: "The medical staff, through its pharmacy and therapeutics function, shall select dosing and monitoring protocols to be followed by the pharmacist performing the service."

On 6/18/12 at 2:45 p.m. during an interview of the PIC stated she was not able to produce a copy of a hospital approved renal dosing protocol. She stated she found a copy of a vancomycin dosing protocol but she said she felt it was a draft. She also found an aminoglycoside dosing protocol.

On 6/18/12 a review of a document entitled INTRAVENOUS VANCOMYCIN DOSING AND MONITORING PROTOCOL indicated it provided guidelines for dosing vancomycin but it did not have a policy number, an effective date, a reviewed date, or a revision date. Further review on 6/19/12 indicated that it stipulated pharmacists were to be trained and to demonstrate their competency to calculate doses and to monitor vancomycin therapy as provided in the procedures.

On 6/18/12 a review of document entitled AMINOGLYCOSIDE DOSING AND MONITORING PROTOCOL indicated that the word "DRAFT" appeared on the upper right corner of the front page of this document. It had no effective, reviewed, or revised dates. Further review on 6/19/12 indicated that it stipulated pharmacists were to be trained and to demonstrate their competency to calculate doses and to monitor aminoglycoside therapy as provided in the procedures. It also provided for using a dosing calculator found at an internet website known as GlobalRPh.com. There was no such provision to use a GlobalRPh calculator documented in the vancomycin document. During an interview of the PIC at 3:44 p.m. on 6/18/12 she stated that pharmacists used this document to adjust gentamicin in the hospital.

On 6/18/12 at 3:57 p.m. during an interview of Pharmacist U, stated she had worked at the hospital for about four years and during that time she had adjusted the doses of vancomycin and aminoglycosides if the physician requested this be done per the "hospital protocol". She said she felt there were protocol in place and had seen draft protocols. At the time she had questioned the former PIC about the status of the "draft" versions. He had told her he was planning to get them approved.

On 6/18/12 a review of a binder entitled CLINICAL indicated it contained monitoring forms for 20 patients (Patients 2 through 21) who had received 22 courses of vancomycin (Patient 16 had three courses) adjusted and monitored by pharmacists. Two of these patients (Patient 6 and Patient 8) had copies of the GlobalRPh vancomycin calculator in their files and one Patient (Patient 15) had evidence that a "Pharmacokinetic Dosing Report" from another hospital had been used to calculate the dose even though the vancomycin dosing document did not mention these dose calculators. The binder contained one monitoring form for one patient (Patient 22) who had received one course of tobramycin (an aminoglycoside) adjusted and monitored by pharmacists. It contained one monitoring form for one patient (Patient 23) who had received one course of gentamicin (an aminoglycoside) adjusted and monitored by pharmacists. It contained monitoring forms for three patients (Patients 24, 25, and 26) who had received one course each of warfarin adjusted and monitored by pharmacists. The dates on these forms indicated these events occurred from March 2011 through January 2012.

On 6/21/12 at 11:10 a.m. during an interview, Pharmacist V reviewed Patient 24's warfarin monitoring profile in the CLINICAL binder with the surveyor. He identified his signature on orders dated 8/4/11 at 12 noon and 8/6/11 at 8:30 a.m. for adjusting warfarin doses. He reviewed Patient 26' s warfarin monitoring profile in the CLINICAL binder. He identified his signature on orders dated 7/8/11 at 2:20 p.m., 7/9/11 (no time), and 7/11/11 at 10 a.m. for adjusting warfarin doses. He stated that he used his protocol to dose warfarin and produced a copy of what he said was "the proposed policy". A review of this document at that time indicated it provided recommended initial doses for warfarin. It did not provide any guidelines for adjusting the dose of warfarin and Pharmacist V verified this observation after he reviewed the document. He stated he had no idea if this protocol was approved when he adjusted the warfarin doses of Patients 24 and 26. He stated that the dosing guidelines should probably be listed in the protocol. He stated he used his experience and his clinical judgment to manage the dosing of warfarin in Patients 24 and 26 rather than any specific guideline in the protocol. He stated if he felt he needed to, he could refer to one of the listed references listed at the end of the protocol.

On 6/20/12 at 11:38 a.m. during an interview of the PIC, she stated she had not been able to find an approved protocol pharmacists would use to adjust doses of warfarin and monitor warfarin therapy. She stated she had checked the Human Relations employee files for her pharmacists and could find no evidence of specific training they had received with regard to any vancomycin or aminoglycoside protocol.

On 6/21/12 at 1:56 p.m. during an interview of the PIC she stated that Pharmacist V had mentioned the anticoagulant protocol. She provided an e-mail and a draft policy. A comparison of the draft policy with the policy provided by Pharmacist V the previous day indicated they were not the same policy. The PIC stated the Pharmacist U and V had told her they had not received any formal training in this hospital with respect to adjusting doses of medications pursuant to hospital approved dosing protocols.

On 6/20/12 a review of the BYLAWS OF NORTH SONOMA COUNTY HEALTHCARE DISTRICT indicated it provided for a "Board of Directors of the District" and that the Board would assure and maintain compliance with Federal, State, and local laws. Under "Article VIII Medical Staff" Section 8.1 it provided for a "Medical Staff" and under Section 8.2 "Bylaws" the Board was given the power to approve the bylaws of the medical staff.

On 6/18/12 a review of the MEDICAL STAFF BYLAWS, RULES, AND REGULATIONS indicated that it stipulated at "10.13 Pharmacy and Therapeutics Committee" (P&T Committee) that the membership of the committee consisted of physicians, a pharmacist, a performance improvement staff member, and support service and administrative personnel. It documented that the "Duties" of this committee was to formulate professional practices and policies regarding the evaluation, appraisal, procurement, storage, distribution, use, safety procedures, and all other matters relating to drugs.

On 6/21/12 at 2:40 p.m. during an interview of the Chair of the Board (COTB) and the Chief Executive Officer (CEO) the CEO stated that all policies and procedures were available to the Board and that the Board was briefed on all policies after approval by the Medical Committee. The COTB stated that the Board was active in its oversight of the hospital. He stated he did not recall that the dosing protocols issue was brought to the attention of the Board.

Based on observation, interview, review of clinical records and hospital policy and procedure the Critical Access Hospital (CAH) failed to ensure that written policies and procedures were followed and the provision of services for Pharmaceutical Services, Infection Control, Nursing Service and Nutritional Service requirements were met as evidenced by:

1. a. Failure to approve protocols, and provide training, for pharmacist adjusted medication doses and monitoring and;
b. Lack of policy and procedure for "clean technique" during dressing changes in the wound care clinic. (See C 271)

2. a. Failure to ensure the pharmaceutical services were managed according to hospital policy and established standards of care and;
b. Storage of opened, undated, multidose medications, and storage of expired medications in patient care areas, and storage of medications with blood, urine and stool specimens. (See C 276)

3. The CAH failed to develop a system for preventing and controlling infections in hospitalized patients when (See C 278):

a. Operating room humidity and air exchanges were not monitored or maintained according to nationally recognized guidelines.

b. A neutropenic (having an abnormally small number of neutrophil cells in the blood) patient was staff cohorted (grouped) with a patient with MRSA (a multi drug resistant organism, has developed resistance to many antibiotics, making infections caused by MRSA more difficult to treat).

c. The general public had access to the PCR testing area (PCR-Polymerase Chain Reaction, the machine reproduced [amplified] a single strand of DNA, making possible earlier diagnosis and treatment of infectious diseases, including the sexually transmitted diseases of chlamydia and gonorrhea.)

d. Refrigerator temperatures were not monitored in one specimen storage refrigerator.

e. The Hydrocollator (used to heat packs used in therapy) temperature was not monitored at one physical therapy site.

f. Dirty and clean linen were stored together at one physical therapy site.

g. Autoclaves (apparatus for sterilization) were not cleaned per manufacturer's guidelines at the primary care clinic.

h. Hand hygiene was not consistently practiced at two of two blood draw stations.

i. Medications were not stored in a clean area away from potentially hazardous organisms.

4. Nutritional Services failed to ensure the nutritional needs of patients were met when (See C 279);

a. Ineffective manual dishwashing technique was used for pots and pans.

b. The CAH's four ice machines were not effectively sanitized.

c. Food production, manual dishwashing sinks, and the kitchen and Emergency Department ice machines lacked air gaps.

d. Physician diet orders were not followed for one diabetic patient.

e. The CAH lacked a comprehensive nutritional analysis for the most commonly prescribed diets and failed to provide a diet manual specific to the hospital's diets.

f. The emergency food supply was inadequate.

g. The meal delivery system allowed potential contamination of patient meals.

h. Cracked food utensils were retained.

i. The CAH lacked a system to monitor the thawing of potentially hazardous foods.

j. Manufacturer's food storage guidance was not followed.

k. One of ten reviewed patient records lacked a timely nutritional assessment.

l. The CAH failed to ensure the availability of a nutritional consultant seven days a week.

m. Patient nutritional assessments were based on staffing rather than patient needs.

n. Nursing services failed to ensure two of ten patients were referred to the Registered Dietician in a timely manner. (See C 296)

o. Nursing services failed to ensure medications were administered in accordance with signed physician orders. (See C 297)

p. Nursing services failed to notify the RD of the presence of a wound at the time of admission, which resulted in a delay of the nutrition assessment.

The cumulative effects of these systemic problems resulted in a diminished ability of the Critical Access Hospital to provide: 1. Safe and effective use of drugs, and storage of medications, to meet the needs of hospital patients, 2. Infection Control measures to reduce the risk of hospital acquired infections, 3. Food services that were optimally safe and nutritious for hospitalized patients and 4. Nursing services that met the individualized needs of hospitalized patients.

Based on observation, review of patient clinical records, document review, and staff interview, the hospital failed to: 1. Ensure that pharmacists only adjusted medication doses and monitored patients according to protocols developed and approved by the hospital organized medical staff through the auspices of the Pharmacy and Therapeutics Committee (responsible for the Pharmaceutical Services in the hospital) and failed to ensure the pharmacist only did this after receiving hospital approved training to adjust and monitor such drug dosage changes according to such protocols as stipulated by hospital policy and as required by state law to ensure that provision of care via these protocols optimized patient care and ensured patient safety. A pharmacist adjusted Patient 1's ceftazidime (an antibiotic) dose to take into account Patient 1's decreased renal (kidney) function on admission to the hospital in the absence of an approved protocol to do so. Other pharmacists adjusted doses and ordered drug levels for twenty patients (Patients 2 through 21) prescribed vancomycin (an antibiotic that can have toxic effects on the kidney), two patients (Patient 22 and 23) prescribed aminoglycosides (tobramycin and gentamicin: intravenous antibiotics which have narrow therapeutic ranges and the potential for significant toxicity to the kidney and the ear), and three patients (Patient 24 through 26) prescribed warfarin (a blood thinner that reduces the ability of the blood to clot which is used to treat blood clots in the body but which also carry the risk of bleeding including severe bleeding). No evidence was provided by the Pharmacist in Charge (PIC) that the hospital had put hospital approved protocols into place to guide the pharmacist in determining dosage adjustments and subsequent monitoring of the drug therapy or that these pharmacists had received training to ensure they understood and complied with the protocols, and

2. The facility failed to ensure provision of care in accordance with written policy and procedure, when the out-patient wound care clinic did not have a policy and procedure regarding, "clean technique," when performing dressing changes. This failure had potential to result in provision of care not in accordance with accepted professional standards, possibly resulting in an increase in wound infections.


Findings:

1. On 6/18/12 a review of the MEDICAL STAFF BYLAWS, RULES, AND REGULATIONS indicated that it stipulated at "10.13 Pharmacy and Therapeutics Committee" (P&T Committee) that the membership of the consisted of physicians, a pharmacist, performance improvement staff member, and support service and administrative personnel. It documented that the "Duties" of this committee was to formulate professional practices and policies regarding the evaluation, appraisal, procurement, storage, distribution, use, safety procedures, and all other matters relating to drugs.

On 6/18/12 a review of Patient 1's clinical record indicated it contained telephone orders from a physician for ceftazidime 1 gram (gm) intravenously (IV) every 8 hours "then per pharmacy staff" and "Vanco" (vancomycin: an IV antibiotic) "as per pharmacy." The nurse wrote the telephone at 5:53 p.m. on 6/16/12.

At 6:30 p.m. a nurse staff member wrote a verbal order for ceftazidime 1 gm IV every 12 hours and indicated this was a renally adjusted dose to be re-evaluated and adjusted the following morning after the morning laboratory blood chemistry results were available. The nurse documented the PIC as the source of the order.

On 6/17/12 at 9:44 a.m. the PIC (Pharmacist In Charge) wrote an order to change the Ceftazidime back to 1 gm IV every 8 hours and to administer vancomycin 1500 mg IV every 24 hours. The PIC also ordered staff to draw a vancomycin trough level (a level taken one-half to one hour before the next scheduled dose) prior to the 6/19/12, dose. The PIC's order indicated that this was being done per physician request.

On 6/18/12 a review of Policy and Procedure 14-02 entitled PHARMACOKINETIC DOSING SERVICE (Effective date 6/92, Reviewed 10/11, no revision date available) indicated the policy of the hospital was as follows: "The pharmacy shall provide a pharmacokinetic dosing service to assist the medical staff in dosing and monitoring patients in order to minimize toxic side effect and to reduce overall facility stay costs by giving therapeutically efficacious doses." Under procedures it stipulated that: "The medical staff, through its pharmacy and therapeutics function, shall select drugs, for example, aminoglycosides, vancomycin, ... for the pharmacokinetic dosing service." It also stipulated: " The medical staff, through its pharmacy and therapeutics function, shall select dosing and monitoring protocols to be followed by the pharmacist performing the service."

On 6/18/12 at 2:45 p.m. during an interview of the PIC she stated she was not able to produce a copy of a hospital approved renal dosing protocol. She stated she found a copy of a vancomycin dosing protocol but she stated she felt it was a draft. She also found an aminoglycoside dosing protocol.

On 6/18/12 a review of a document entitled INTRAVENOUS VANCOMYCIN DOSING AND MONITORING PROTOCOL indicated it provided guidelines for dosing vancomycin but it did not have a policy number, an effective date, a reviewed date, or a revision date. Further review on 6/19/12, indicated that it stipulated pharmacists were to be trained and to demonstrate their competency to calculate doses and to monitor vancomycin therapy as provided in the procedures.

On 6/18/12 a review of document entitled AMINOGLYCOSIDE DOSING AND MONITORING PROTOCOL indicated that the word "DRAFT" appeared on the upper right corner of the front page of this document. It had no effective, reviewed, or revised dates. Further review on 6/19/12, indicated that it stipulated pharmacists were to be trained and to demonstrate their competency to calculate doses and to monitor aminoglycoside therapy as provided in the procedures. It also provided for using a dosing calculator found at an internet website known as GlobalRPh.com. There was no such provision to use a GlobalRPh calculator documented in the vancomycin document. During an interview of the PIC at 3:44 p.m. on 6/18/12, she stated that pharmacists used this document to adjust gentamicin in the hospital.

On 6/18/12 at 3:57 p.m. during an interview of Pharmacist U, she stated she had worked at the hospital for about four years and during that time she had adjusted the doses of vancomycin and aminoglycosides if the physician requested this be done per the "hospital protocol". She stated she felt there were protocol in place and had seen draft protocols. At the time she had questioned the former PIC about the status of the "draft" versions. He had told her he was planning to get them approved.

On 6/18/12 a review of a binder entitled CLINICAL indicated it contained monitoring forms for 20 patients (Patients 2 through 21) who had received 22 courses of vancomycin (Patient 16 had three courses) adjusted and monitored by pharmacists. Two of these patients (Patient 6 and Patient 8) had copies of the GlobalRPh vancomycin calculator in their files and one Patient (Patient 15) had evidence that a "Pharmacokinetic Dosing Report" from another hospital had been used to calculate the dose even though these calculators were not mentioned in the vancomycin dosing document. The binder contained one monitoring form for one patient (Patient 22) who had received one course of tobramycin (an aminoglycoside for) adjusted and monitored by pharmacists. It contained one monitoring form for one patient (Patient 23) who had received one course of gentamicin (an aminoglycoside) adjusted and monitored by pharmacists. It contained monitoring forms for three patients (Patients 24, 25, and 26) who had received one course each of warfarin adjusted and monitored by pharmacists. The dates on these forms indicated these events occurred from March 2011 through January 2012.

On 6/20/12 at 11:38 a.m. during an interview of the PIC, she stated she had not been able to find an approved protocol pharmacists would use to adjust doses of warfarin and monitor warfarin therapy. She stated she had checked the Human Relations employee files for her pharmacists and could find no evidence of specific training they had received with regard to any vancomycin or aminoglycoside protocol.

On 6/21/12 at 11:10 a.m. during an interview of Pharmacist V, he reviewed Patient 24's warfarin monitoring profile in the CLINICAL binder with the surveyor. He identified his signature on orders dated 8/4/11 at 12 noon and 8/6/11 at 8:30 a.m. for adjusting warfarin doses. He reviewed Patient 26's warfarin monitoring profile in the CLINICAL binder. He identified his signature on orders dated 7/8/11 at 2:20 p.m., 7/9/11 (no time), and 7/11/11 at 10 a.m. for adjusting warfarin doses. He stated that he used his protocol to dose warfarin and produced a copy of what he said was "the proposed policy". A review of this document at that time indicated it provided recommended initial doses for warfarin. It did not provide any guidelines for adjusting the dose of warfarin and Pharmacist V verified this observation after he reviewed the document. He stated he had no idea if this protocol was approved when he adjusted the warfarin doses of Patients 24 and 26. He stated that the dosing guidelines should probably be listed in the protocol. He stated he used his experience and his clinical judgment to manage the dosing of warfarin in Patients 24 and 26 rather than any specific guideline in the protocol. He stated if he felt he needed to he could refer to one of the listed references listed at the end of the protocol.

On 6/21/12 at 1:56 p.m. during an interview, the PIC stated that Pharmacist V had mentioned the anticoagulant protocol. She provided an e-mail from Pharmacist V and a draft policy. A comparison of the draft policy with the policy provided by Pharmacist V earlier indicated they were not the same policy. The PIC stated that Pharmacist U and V had told her they had not received any formal training in this hospital with respect to adjusting doses of medications pursuant to hospital approved dosing protocols.




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2. During interview on 6/20/12 at 9:05 a.m., Registered Nurse (RN) F stated dressing changes performed in the out-patient wound care clinic were done using clean (not sterile) technique, since most of the wounds were chronic. RN F stated a few procedures performed in the clinic used sterile technique, such as some punch biopsies (samples taken for biopsy) and application of a specialized product to treat diabetic foot ulcers performed by the physicians.

During observation of a dressing change on 6/20/12 at 10:50 a.m., RN F applied a foam-type dressing to Patient 63's lower leg wound and to two areas on the balls of both feet where the podiatrist had shaved down calluses with a scalpel. RN F did not wear gloves when she applied the dressings.

During interview on 6/20/12 at 11 a.m., Clinical Educator G was asked to provide a policy and procedure for clean technique for dressing changes.

During interview on 6/21/12 at 1:30 p.m., Clinical Educator G, stated the facility and the wound care clinic did not have a policy and procedure regarding wound dressing changes using clean technique, and agreed that one should be adopted.

Based on observation, staff interview and document review, the hospital failed to ensure that the pharmaceutical services were managed according hospital policy and established standards of care, and failed to ensure that mislabeled or otherwise unusable medications were not available for use by hospital patients as evidenced by:

a. The failure of the hospital to provide a stop date for ketorolac (a non-steroidal anti-inflammatory agent [like Motrin] used to treat pain but which must not be given for more than five days due to the risk of kidney damage after that time) in the policy regarding stop dates as recommended in published guidelines the American Society of Health System Pharmacists, a nationally recognized organization that sets standards of practice for hospital pharmacies and as stipulated by hospital policy (see finding a).

The failure of the hospital to provide written procedures for pharmacists to follow in its AUTOMATIC STOP ORDERS policy that would ensure physicians were notified in a consistent fashion of pending discontinuation of drugs and which would ensure that physicians would be notified of the pending discontinuation of ketorolac so that they could order an alternate pain medication if so required (see finding a).

b. The failure of the hospital to establish unambiguous orders for rapid acting insulin on a pre-printed order set in Patient 27's clinical record: it was not clear when a physician checked the orders for rapid acting insulin if the physician had approved one type of insulin, a second type of insulin, or both types of insulin (see finding b).

c. The failure of the hospital to monitor and record the temperatures of refrigerated vaccines in one of two refrigerators used to store vaccines in the Healdsburg Primary Care Clinic (HPC) as recommended in guidelines published by the Centers for Disease Control and as required by hospital procedure (see finding c) which could result in the failure of the staff to detect storage of vaccines outside of manufacturer's recommendations with potential loss of potency of these medications and subsequent administration to patients resulting in a potential inadequate immune response to the vaccine.

d. The failure of the hospital to ensure staff stocked the crash cart in the Emergency Department according to the content list and the failure of the hospital list to ensure that all posted expiration dates were accurate so that staff would know when these medications actually expired. Failure to staff an emergency drug supply as documented by the content list could result in too little drug being available (the cart was short of 0.9% sodium chloride syringes used to flush intravenous lines) or that too much drug was administered if the prescriber ordered that the drug be given in units of "vial" instead of milligrams (the cart contained 10 milligram (mg) vials of verapamil not 5 mg vials as documented on the content list). The inaccurate expiration dates on the content list mislabeled the affected drugs (see finding d).

e. The failure of the hospital to ensure the content list of the Malignant Hyperthermia (MH: a rare but potentially lethal side effect of certain drugs used in inducing and maintaining anesthesia) cart reflected the published guidelines of the Malignant Hyperthermia Association of the United States (MHUAS) which staff identified as the organization whose guidelines the hospital would follow and which is a nationally recognized organization that set standards of care for this potential adverse medical outcome (see finding e).

f. The failure of the hospital to store warmed solutions in the only warmer located in the Surgery Department according to hospital guidelines and the manufacturer's guidelines for storing their solutions at warmed temperatures. All solutions were potentially expired as: three of five intravenous (IV) solutions had been labeled by staff to have expired the day prior to inspection of the warmer. All seven IV solutions were stored above the maximum temperature stipulated by the manufacturer rendering them unusable. All four irrigation solutions had expired one day prior to the inspection if the staff had labeled them with 14 day expiration dates as stipulated in hospital policy (see finding f).

g. The failure of the hospital to label one out of four specialized IV bags (to which staff had docked a vial of medication) stored in active stock in the pharmacy with the date of assembly. As such an IV bag/vial assembly had a 15 day expiration date according to manufacturer's specifications, it was not possible to tell if this bag was expired or not, therefore it was not usable for patients (see finding g).

h. The failure of the hospital to ensure that one vial of expired medication (Kenalog-10: an anti-inflammatory steroid) was removed from active stock in the HPC and the failure of the hospital to ensure hospital anesthesiologists or hospital staff removed five expired medications from the anesthesia cart in Operating Room #2 (one labetalol vial: used to treat high blood pressure, two rocuronium vials: a paralyzing agent, one neostigmine vial: used to reverse the effects of paralyzing agents, and one glycopyrrolate vial; used to reduce airway secretions) and one expired medication from the anesthesia cart in Operating Room #1 (one labetalol vial) (see finding h). The failure of the hospital to ensure that the hospital policy for establishing the expiration date for opened (punctured) multiple-dose vials (MDVs) was in agreement with the United States Pharmacopeial Convention (USP) Section 797 guidelines. The hospital policy gave opened MDVs a 30 day expiration date or one established by the manufacturer while USP 797 give such opened MDVs a 28 day expiration date or as established by the manufacturer (see finding i).

i. The failure of the hospital to ensure staff stocked ceftriaxone, an antibiotic, in a properly labeled storage pocket in the HPC. The HPC staff had placed a 250 mg vial of ceftriaxone in a pocket labeled one 1 gm (gram). If staff depended solely on the pocket label, they could potentially under-dose a patient for whom a 1 gm dose had been ordered (see finding i).

j. Expired glucose drink, for glucose tolerance testing was stored in a refrigerator used for storing blood, urine and stool samples for laboratory testing, with potential for administration of ineffective, contaminated medication.

k. Four of six multidose wound treatment medications were not labeled with the date opened, and two of six medications were past the expiration date, with potential that ineffective medications were available for patient use.

Findings:

a. On 6/21/12 a review of Policy and Procedure 10-5 entitled AUTOMATIC STOP ORDERS (Effective Date: 6/92, Revised: 2/01, Reviewed: 10/11) indicated the hospital policy was: "There shall be an automatic cancellation or temporary stoppage of orders on specific toxic and dangerous drugs as established by the medical staff. The medical staff shall establish reasonable time limits for specified drugs."

It also provided that the drug was not to be stopped until the prescriber had been provided an opportunity to verify that the drug was to be stopped, continued, or modified. However, there was no established procedure in this policy directing staff how they were to notify physicians of impending discontinuation of a medication.

It provided for seven day stop dates for six classes of drugs and all the others were assigned a 30 to 45 stop date period. Ketorolac was not included among the six classes of drugs with an automatic seven day stop date so based on the policy, this drug would be automatically stopped after 30 to 45 days. Ketorolac has the potential for significant toxicity to the kidney and stomach, and significant risk of bleeding and adverse effects to the heart if used contrary to manufacturer guidelines. The manufacturer has documented in a boxed warning in the Food and Drug Administration (FDA) approved product labeling that the drug is not to be given for more than five days.

On 6/21/12 at 4:30 p.m. during an interview of Pharmacist V, he stated there was a process to notify physicians of impending discontinuation of drug orders. He stated that a set of "Expiring Drug Orders" was printed out each Monday covering the period from that Monday to the following Monday.

On 6/21/12 at 4:28 p.m. during an interview of the Pharmacist in Charge (PIC) she stated that ketorolac should have been included in Policy and Procedure 10-5. She stated the pharmacy computer system provided for a 5 day stop date for ketorolac but there was no policy to do this. The surveyor pointed out that the current process could miss a ketorolac order that was ordered on a Tuesday and would be stopped sometime during the following Sunday and the PIC verified this observation. She verified there was no hospital approved established procedure documented in an approved written policy to notify physicians of impending discontinuation of medications.

b. On 6/19/12 at 8:37 a.m., during a medication pass on the medical surgical unit, RN N administered two units of Novalog Insulin (Insulin Aspart: a rapid acting insulin) to Patient 27 via subcutaneous (into a layer of tissue just under the skin) injection.

On 6/19/12 a review of Patient 27's clinical record indicated it contained a preprinted order set entitled PREPRINTED SUBCUTANEOUS INSULIN ORDERS. A date, "4/2/07", was printed in the lower left corner. The order set provided for the selection of insulin regimens based on a patient's blood sugar levels. It also provided for selection of the type of insulin to be used via a checkbox. There were two insulin types available for selection: regular insulin and "Lispro (Humalog or Novalog) ...". The problem: Humalog is insulin lispro and Novalog in insulin aspart. Both are rapid acting insulins with an onset of action that is faster than regular insulin but they have chemically different structures and are not generically equivalent. The order provided one generic name of one type of rapid acting insulin (lispro) but provided two brand names of chemically distinct insulins (Humalog and Novalog). As written, it was not clear if one should only dispense insulin lispro (Humalog) as the order set failed to indicate that Novalog was chemically distinct from Humalog and there was no evidence provided that the hospital intended to permit the hospital pharmacy to dispense either insulin as a "therapeutic equivalent" drug (chemically distinct drugs that produce essentially the same result) but had failed to add "Aspart" to "Lispro" at the beginning of the order.

On 6/19/12 at 2:45 p.m. during an interview of the PIC, she stated the date, 4/2/07 in the lower left corner of the order set was the date it was approved for use by the hospital. She verified that insulin lispro was chemically distinct from insulin aspart. She stated she would prefer the order set to read "Rapid acting insulin (Humalog or Novalog)". She stated that the order set was currently under review for change.

c. The Centers for Disease Control and Prevention (CDC) in its GENERAL RECOMMENDATIONS ON IMMUNIZATION published in the 1/28/11 Morbidity and Mortality Weekly Report has documented recommendations for the monitoring of temperatures at which vaccines are stored: "Temperatures for ...the refrigerator should be documented twice a day and recorded ...even if an automated monitoring system is used, temperatures still should be manually checked and recorded twice each day." The CDC has documented in this same source that: "Failure to adhere to recommended specifications for storage and handling of immunobiologics can reduce or destroy their potency, resulting in inadequate or no immune response in the recipient." Vaccines are an "immunobiologic."

On 6/20/12 at 1:53 p.m. during an inspection of the Healdsburg Primary Care Clinic (HPC) the surveyor noted two refrigerators were located in the laboratory section of the HPC. During an interview of Healdsburg Primary Care Clinic Manager Q at the time, she identified one of the refrigerators as being used for the Vaccines for Children Program (VFCP: a government program that provides vaccines to children on Medicaid). The second refrigerator contained vaccines for patients seen in the HPC other than those in the VFCP. Inspection of the temperature logs maintained by the facility for these refrigerators indicated that both logs provided for twice daily monitoring and recording of temperatures and Manager Q verified this was the expected practice at the HPC.

A review of the temperature log for the second refrigerator indicated that staff had not recorded either the "am" (morning) or the "pm" (evening) temperatures for this refrigerator on 4/2/12 and on 5/10/12 and the "pm" temperature on 5/9 (just prior to 5/10/12).

On 6/20/12 at 4:58 p.m. during an interview the PIC stated she could not provide a reason why the hospital would not follow the CDC recommendations regarding the documentation of temperatures of vaccine storage refrigerators twice a day.

d. On 6/22/12 at 11:58 a.m. an inspection of Crash Cart #6 in the Emergency Department (ED) indicated it had an external content list that served as a label for the medications stored in this emergency supply. This external content list also contained expiration dates for the medications contained in this supply. An accurate expiration date is part of a medication label. Inspection of the cart indicated the following:

1. The cart contained three 10 milliliter pre-filled syringe of 0.9% sodium chloride (used to flush IV lines among other things) while the content list indicated it contained five such syringes.

2. The cart contained two 10 mg vials of verapamil (used to treat irregular heart rhythms) while the content list indicated it contained two 5 mg vials of verapamil.

3. The calcium chloride syringes (used to stimulate heart contractions) was labeled by the manufacturer to expire 9/2013 while the content list documented they would expire 6/1/12.

4. The single pre-mixed bag of dopamine (used to increase blood pressure in patients whose blood pressure is too low) was labeled by the manufacturer to expire 11/2012 while the content list documented it would expire 6/2012.

5. The epinephrine syringes (used to stimulate return of spontaneous circulation) were labeled by the manufacturer to expire 4/1/13 while the content list documented they would expire 7/1/12.

6. The sodium bicarbonate syringes (used to lower the acidity of a patient's blood) were labeled by the manufacturer to expire 2/1/13 while the content list documented the first syringe to expire would do so on 8/1/12.

e. On 6/22/12 at 1:13 p.m. an inspection of the single MH Cart stored in the Surgery Department indicated staff did not stock the cart according to the posted content list. Also the posted content of the cart did not adhere to the MHAUS guidelines (the cart was stocked according to MHAUS guidelines). The external content list documented that the MH Cart contained two 100 mg lidocaine syringes (used to treat irregular heart beats) while inspection indicated the cart contained three such syringes (in agreement with MHAUS guidelines). The external content list documented the cart contained six 50 ml sodium bicarbonate 8.4% syringes (used to decrease the acidity of the blood) while inspection indicated it contained five 50 ml sodium bicarbonate 8.4% syringes (in agreement with MHAUS guidelines). The external content list indicated the cart contained two 100 mg furosemide vials (used to increase urine flow) while inspection indicated it contained four 40 mg vials of furosemide (in agreement with MHAUS guidelines). The external content list documented the MH Cart contained two 500 ml bags of 20% mannitol (used to increase urine flow). While inspection indicated that the MH Cart did not contain this medication this would be in agreement with MHAUS recommendations as the dantrolene (used to treat MH) that must be stored in these carts contains 3 grams (gm) of mannitol in each vial.

On 6/22/12 at 1:42 p.m. during an interview of the Director of Perioperative Services he stated the hospital followed MHAUS guidelines to stock the cart. He could not say why the hospital would not follow MHAUS guidelines (as evidenced by a content list that was not congruent with MHAUS guidelines).

On 6/22/12 at 3:35 p.m. during an interview of the Pharmacist in Charge she stated that the cart should be stocked according to MHAUS guidelines and that no mannitol was needed in the cart as each dantrolene vial contained 3 gm of mannitol.

f. On 6/22/12 at 1:52 p.m. during an inspection of the single warmer in the Surgery Department indicated that the temperature registered 117 deg F on the external temperature gauge for the area in which staff stored solutions. Inspection of the warmer indicated that it contained three 1000 ml plastic pour bottles of 0.9% sodium chloride for irrigation all labeled by hospital staff to expire on 7/2/12, four 1000 ml IV bags of lactated ringers (used to replace fluid and vital minerals) two of which were labeled by staff to have expired 6/21/12. It contained one 1000 ml IV bag of 0.9% sodium chloride labeled by staff to have expired 6/21/12. The manufacturer's labels documented that Manufacturer A manufactured all these solutions. During an interview of the Director of Perioperative services at that time, he verified that the solutions dated 6/21/12 were expired.

A review of a posted policy and procedure on the door of the warmer entitled FLUID WARMER: PARAMATERS FOR STORAGE OF IV FLUIDS (Effective 6/05, Reviewed 10/05, Revised 11/05) indicated it documented that "A maximum temperature of 104 deg F will not be exceeded." It documented that IV solutions and irrigation solutions in plastic pour bottles "...will be labeled with a two (2) week expiration date."

Manufacturer A has documented that IV solutions greater than 150 ml in volume can be stored up to 104 deg F for no longer than 14 days. Manufacturer A has documented that its plastic pour bottles of irrigation solutions should be stored for 30 days at temperatures not to exceed 104 deg F and up to 72 hours at temperatures not to exceed 150 deg F.

Therefore, the IV solutions were not stored according to manufacturer's parameters or hospital policy and were unusable for patients. The irrigation solutions would only have been good for three days at 117 deg F. If staff labeled these bottles with a two week expiration date as provided for by hospital procedure that would mean the solutions had been put in the warmer on 6/18/12 and had expired on 6/21/12.

g. On 6/18/12 at 10:19 a.m. during an inspection of the pharmacy IV Room the surveyor found four IV piggyback bags to which staff had attached (or docked) vials of injectable medication via a trademark connecting device. During an interview of the PIC at that time she stated the device prevented the mixing of the medication with the IV fluid until activated on the floor by the nurse.

The trademark device was an integral part of 50 ml and 100 ml IV piggyback bags from Manufacturer A. Manufacturer A has documented that when a vial of medication is "docked" but not yet activated to these specialized IV piggyback bags, the resulting medication assembly has a shelf life of 15 days (it lists five drugs that have a 30 day shelf life in the docked assembly).

Three of these four bags had labels on them indicating when the vials had first been docked to the specialized IV piggyback bags but one did not. Therefore it was not possible to determine the shelf life of this unlabeled IV piggyback. During an interview of the PIC at that time she verified this finding and verified these bags were among active stock.

h. The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines ...USP' s drug standards are enforceable in the United States by the Food and Drug Administration. The USPs revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death to patients that could result from microbial contamination and excessive bacterial toxins among other things." Under the section "Single-dose and multiple-dose containers" it documents that opened multi-dose vials (those that have been punctured with a needle) have a beyond use date of 28 days "unless otherwise specified by the manufacturer."

On 6/22/12 are review of Policy and Procedure 21-06 entitled MULTI-DOSE VIALS:USE OF (Effective: 3/98, Reviewed: 10/11, Revised 12/06) indicated that opened multi-dose vials could be used for 30 days after opening or the beyond use date specified by the manufacturer if shorter than 30 days.

1. On 6/20/12 at 4:22 p.m. during an inspection of the Family Practice Nursing Station in the HPC indicated staff had labeled an open vial of Kenalog-10 with an auxiliary label on which the staff recorded the open date as 5/10/12 and the date of expiration as 6/10/12 (10 days prior to the survey and 31 days after it was opened).

On 6/22/12 at 2:09 p.m. during an inspection of the Operating Room #2 Anesthesia Cart the surveyor found one open vial of labetalol (used to lower high blood pressure) that a physician had labeled as being opened on 5/5/12 (and would have been out of date on 6/2/12 by UPS 797 standards on 6/4/12 by hospital policy). The surveyor also found two open vials of rocuronium (a paralyzing agent used to relax muscles during surgery) both labeled with open dates of "5/9" (out of date on 6/6/12 by UPS 797 standards and on 6/8/12 by hospital policy). The surveyor found an open vial of neostigmine (used to reverse the effects of paralyzing agents after surgery) dated 5/10/12 (out of date 6/7/12 by USP 797 standards and 6/9/12 by hospital policy). The surveyor found one open vial of glycopyrrolate (used to control airway secretions during surgery) dated 5/17/12 (out of date 6/14/12 per USP 797 standards and 6/16/12 per hospital policy).

On 6/22/12 at 2:2 p.m. during an inspection of the Operating Room #1 Anesthesia Cart, the surveyor found one open labetalol vial dated as opened on 5/21/12 (out of date 6/18/12 per USP 797 standards and 6/20/12 per hospital policy).

On 6/22/12 at 9:25 a.m. during an interview of the PIC she stated the policy regarding the beyond use dating of multi-dose vials should stipulate a 28 day period (or as per the manufacturer) expiration date after opening as recommended in USP Section 797, not 30 days as per the hospital policy.


i. On 6/20/12 during an inspection of the Family Practice Nursing Station located in the HPC the surveyor found a 250 mg vial of ceftriaxone (an injectable antibiotic) in a drug storage pocket labeled to contain 1gm of ceftriaxone. The label on the drug storage pocket mislabeled the vial of ceftriaxone stored there.



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j. During an observation, on 6/19/12 at 9:35 a.m., the refrigerator at an off-site blood draw facility, operating under the hospital license, contained blood samples, and bottles of glucose drink, given to patients for glucose tolerance testing.

Inspection of the three bottles of Glucose Drink-050 indicated the contents were used for glucose tolerance tests, upon prescription of a physician. Two bottles of lemon lime flavor had the expiration date 2012-02, one bottle of orange flavor expired 2011-10.

The freezer section was overflowing with ice. No thermometer was visible in the refrigerator. Certified Lab(oratory) Assistant P stated the temperature in the refrigerator was not monitored.

During an interview, on 6/19/12 at 10:50 a.m., CLA P, stated urine samples and stool samples, in specimen bags, were stored in the refrigerator, as well as some blood samples, until the samples were transported to the main hospital lab.




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k. During concurrent observation and interview at the out-patient would care clinic on 6/20/12 at 9:30 a.m., RN F stated most of the medications used by the clinic were multi-dose topical creams and ointments in tubes, solutions to clean wounds, and multi-dose injectable 2% lidocaine used as a local anesthetic. RN F stated the clinic's practice was to label all such medications with the date they were opened, and they were good for 28 days from the date as long as they were not contaminated. RN F stated their practice was to write the open date on the medication with a pen or use an adhesive to apply to the medication with the open date.

During subsequent observations in the clinic Exam Rooms 1, 2, and 4 at 9:30 a.m. and 9:45 a.m., the following medications, as well as other supplies, were found open and not labeled with opened dates or past the 28-day timeframe:

Clobetasol ointment (a synthetic corticosteroid used for inflammatory or itchy skin conditions, i.e., psoriasis), opened 5/18/12
Hydrogen peroxide, no open date
2% lidocaine multi-dose vial, no open date
Gentian violet (used as a stain or as an anti-infective) multi-dose vial, no open date
Medihoney ointment (used to promote wound healing), opened 2/29/12
Wound cleanser, no open date
Insulin syringes, expiration date 12/2006

During interview on 6/21/12 at 2:10 p.m., Pharmacist in Charge (PIC) stated the facility did not have a policy regarding topical medications. The PIC stated best practice was to label all multi-dose topical preparations when opened and they could then be used for 28 days if not contaminated.

The facility's Pharmacy Policy 21-06, titled, "Multi-Dose Vials: Use of," last revised 12/06, indicated the following: "All multi-dose vials will be dated and initialed upon opening by the person opening the vial.....Multiple-use sterile drugs may be used up to thirty (30) days after initial opening provide they are dated, contain a preservative and show no evidence of contamination....Multiple-use sterile drugs not meeting these specifications shall be discarded...."

Based on observation, interview, and review of clinical records and hospital policies and procedures, the hospital failed to implement a system for identifying, reporting, investigating and controlling infections as evidenced by the failure to ensure that:

a. Operating room humidity and air exchanges were monitored and maintained at levels recommended to decrease risk of surgical site infections.

b. Patient 62, with elevated risk of infection due to neutropenia (abnormally small number of neutrophil cells in the blood), was protected from exposure to multi drug resistant bacteria (Patient 1).

c. Access to PCR testing equipment (PCR-Polymerase Chain Reaction, the machine reproduced [amplified] a single strand of DNA, making possible earlier diagnosis and treatment of infectious diseases, including the sexually transmitted diseases of chlamydia and gonorrhea) was limited to laboratory staff which allowed potential for: breach of patient privacy, access to chemicals and medical waste by the general public, and potential contamination of DNA testing

d. Refrigerator temperatures were monitored and maintained for safe storage of laboratory samples at one of two outpatient blood draw sites with potential deterioration of the samples, and that laboratory specimens were stored separately from medications.

e. Hydrocollator (used to heat packs used in therapy) temperature was monitored daily at one of two outpatient physical therapy sites with potential for bacterial growth on patient care items.

f. Dirty and clean linen was stored separately at one of two out patient physical therapy sites with potential contamination of clean linen with disease causing organisms.

g. Autoclave equipment was cleaned per manufacturer's guidelines at the primary care clinic with potential accumulation of hazardous bacteria.

h. Hand hygiene was consistently practiced at two of two outpatient blood draw sites with potential exposure of patients or staff to disease causing microorganisms, and contamination of blood samples

i. The Primary Care Clinic failed to store medications in a clean area away from area where potentially infected bodily fluids were tested and contaminated medical instruments were cleaned and autoclaved. Such close proximity to dirty areas could result in contamination of medication or medication containers which could then result in the spread of infection.


Findings:

a. During a tour, on 6/20/12 at 9:35 a.m., of the facility perioperative suite, a humidity gauge hung on the wall of Operating Room 2 beside the entrance door. The humidity read 68%. During a team meeting, on 6/20/12 at approximately 1:40 p.m., Life Safety Code Surveyor reported he had observed the humidity level in Operating Room 2 to be 68% during his morning tour of the perioperative areas.

During review, of the Operating Room Temperature Log, and concurrent interview on 6/20/12 at 9:35 a.m., the Director of Perioperative Services stated that the facility did not monitor humidity levels in the operating rooms.

During an interview, on 6/21/12 at 1:55 p.m., the Director of Perioperative Services stated that it was his understanding that the operating rooms had an air exchange rate of "25 to 30 air exchanges per hour.", however he did not have any documentation of the air exchange rate. The Director of Perioperative Services stated Facility Manager D would have the necessary documentation.

During an interview, on 6/21/12 at 10:45 a.m., Maintenance Tech L stated that balances of the air exchange in the perioperative area had been done about three years previously, however the report was missing.

During an interview, on 6/21/12 at 3 p.m., the Facility Manager D stated he could find no evidence of maintenance of the air exchange equipment and he did not know when the equipment had last been checked.

Review, on 6/27/12 at 9:30 a.m., of Recommended Practices for a Safe Environment of Care, Perioperative Standards and Recommendations, published by the Association of perioperative Room Nurses, (AORN), 2012, indicated Recommendation V.b. included: "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating room...High humidity increases the risk of microbicidal growth in areas where sterile supplies are stored or procedures performed.
Recommendation V.b.2. stated, "Humidity should be monitored and recorded daily...".

Recommendation V.d.1. indicated: "The minimum rate of total air exchanges per hour should be maintained at a constant level as follows. Operating Room: minimum rate of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges". Air in the perioperative environment can contain microbial laden dust, lint, skin flakes and respiratory droplets. Properly functioning air exchanges remove contaminants from the air and away from the sterile field.

b. During an initial tour and observation of the Medical-Surgical Unit, on 6/18/12 at 10:45 a.m., the door to room 117, was open to the hall. An isolation cabinet hung in the hallway between the doors to room 117 and 119. A sign on the door of room 119 stated, "Contact Precautions". Hospital staff were observed entering and leaving room 119, wearing protective disposable gowns and gloves. Registered Nurse M stated the patient in room 119, (Patient 1) had an open wound infected with a multi-drug resistant organism, which she identified as MRSA, ( MRSA-Methicillin Resistant Staph Aureus).

MRSA, a multi drug resistant organism, has developed resistance to many antibiotics, making infections caused by MRSA more difficult to treat.
Center for Disease Control, (CDC), 2007 Guideline for Isolation Precautions-Preventing Transmission of Infectious Agents in Healthcare Settings, direct that patients with MRSA be cared for with Contact Precautions to prevent spread of the infection to others. Contact Precautions include meticulous hand hygiene, protective gowns and gloves worn by healthcare personnel for direct contact with the patient or the patient's environment. The CDC Guidelines also recommend that "...assigning or cohorting of healthcare personnel to care only for patients infected or colonized with a single target pathogen limits further transmission of the target pathogen to unaffected patient(s)". (Cohort, to place into a group.)

A review, on 6/18/12 at 2:20 p.m., of the clinical record for Patient 62, assigned to room 117, indicated the patient had been admitted with diagnoses that included fever. Review, of the admission history and physical, dated 6/15/12, indicated Patient 62 had received chemotherapy earlier in the week. (Chemotherapy, treatment of disease with chemicals toxic to organisms or cancer cells, unfortunately chemotherapy sometimes is toxic to normal fast growing human cells, for example the bone marrow, which makes blood cells.)

Review, of Patient 62's laboratory studies, dated 6/18/12 at 5:45 a.m. indicated Patient 62 had a white blood cell, (WBC), count of 0.96 K/UL, and an absolute neutrophil count of 0.59 K/UL, both low values.
WBCs are measured in thousands (K) per cubic milliliters (UL).
Patient 62 had a WBC of 960, and an absolute neutrophil count of 590, (ANC), which placed Patient 62 at increased risk for infection.

Review of hospital policy Neutropenia Precautions, Policy#3.05, on 6/19/12 at 1:25 indicated the definition of neutropenia was an absolute neutrophil count of less than 1000/cubic millimeter. The facility policy stated Neutropenic Precautions were to be instituted by physician order, and were designed to provide an environment in which there was lesser chance of exposure to others with an infection, or environmental contaminants.

Normal adult WBC ranges between 4.0-11.5 K/UL and normal adult absolute neutrophil count range between 1.4-9.2 K/UL. WBCs, produced in the bone marrow, fight infection, and are part of the body's immune system. Neutrophil is one kind of white blood cell that destroys infectious bacteria in the blood; absolute neutrophil count (ANC), is the measure of the number of infection fighting blood cells. The body cannot defend itself against infection in the absence of neutrophils and infection can spread quickly and be life threatening.

During an observation, on 6/18/12 at 3:20 p.m., the door to Patient 62's room was closed. It was noted that the same licensed staff had been assigned to care for both Patient 62 in room 117, and Patient 1 in room 119. The sign for Contact Precautions still hung on the door of room 119.

Review, of Patient 62's complete blood count on 6/19/12, indicated Patient 62's WBCs were 0.77 K/UL=770, and ANC was 0.33=330, both lower than the previous day, further increasing the risk of infection for Patient 62.

Later observation, on 6/19/12 at 2:35 p.m., revealed that the same licensed staff had again been assigned to care for both Patient 1, with contact precautions, and Patient 62, who was at increasingly high risk for infection.

During a concurrent interview, Registered Nurse N stated she didn't think a patient with neutropenia assigned to the same nurse caring for a patient in contact precautions was the best assignment.

A Clinical Journal of Oncology Nursing, Volume 10, Number 2, 04/2006, article entitled, "Care of Patients with Neutropenia", stated that while putting patients with neutropenia into Protective Isolation is no longer recommended, other nursing practices do provide some protection. These practices include minimizing exposure to infectious people.

c. During an initial tour, on 6/18/12 at 10:30 a.m., a door on a main hospital hallway was observed propped open with a chair. The open door had a sign that read "Authorized Personnel. Gloves required". The room was dark.

During a concurrent interview, the Clinical Lab Manager, stated the room housed the hospital's PCR machine, used to examine chlamydia and gonorrhea samples. (PCR-Polymerase Chain Reaction, the machine reproduced (amplified) a single strand of DNA, making possible earlier diagnosis and treatment of infectious diseases, including the sexually transmitted diseases of chlamydia and gonorrhea.)

During the subsequent observation in the room, it was noted that several specimen containers, labeled with patient names, sat on a table just inside the door. The room also held large unlocked refrigerators used to store laboratory reagents. On the floor between the PCR machine and the door to the hall, were two receptacles connected to the PCR machine. One container was labeled "reagent", the other was labeled "waste".

During an interview, on 6/20/12 at 3 p.m., Clinical Lab Manager stated when the door to the PCR room was left open, unrestricted access was allowed to contaminated specimens, enzymes and wastes. The Clinical Lab Manager acknowledged that patient privacy could be compromised when labeled specimens were left in a space with public access.

During an observation, on 6/21/12 at 10:35 a.m., the door to the empty PCR room was again left open. A large suitcase sat on the floor in the room.

Online research, at www.oahpp.ca/services, on 6/28/12, at 2:20 p.m., indicated that PCR specimen integrity is of critical importance as results can be compromised by introduction of extraneous DNA, i.e., skin flakes, dust. To prevent compromise of the DNA results, laboratory protocols suggested PCR analysis be done in a space used only for PCR analysis.

d. During an observation, on 6/19/12 at 9:35 a.m., the refrigerator at an off-site blood draw facility, operating under the same license, contained blood samples, and bottles of glucose drink, given to patients for glucose tolerance testing. The freezer section was overflowing with ice. No thermometer was visible in the refrigerator.

During an interview, on 6/19/12 at 10:50 a.m., Certified Lab Assistant P, (CLA P), stated urine samples and stool samples, in specimen bags, were stored in the refrigerator, as well as some blood samples, until the samples were transported to the main hospital lab. CLA P stated the temperature in the refrigerator was not monitored.

Review, on 6/19/12 at 2:45 p.m., of hospital policy 5.02, titled "Refrigerators, freezers, care of, monitoring of", specified that food and pharmaceutical refrigerators and freezers were to be monitored daily, but did not describe the care of specimen refrigerators.

e. During an observation, on 6/19/12 at 10:15 a.m., at an off-site physical therapy office, licensed under the hospital, a hot pack Hydrocollator unit, used to heat packs used in therapy, sat in a back room, next to a refrigerator. The room contained a miscellaneous equipment, across the hall was an unoccupied office for the physical therapists.

Concurrent review, of the temperature logs for the Hydrocollator unit revealed that the temperature of the unit had been monitored once a month in June, July, August and November, and not monitored at all in September,October, or December of 2011. Review of the temperature log for 2012 indicated the temperature had not been checked in January, and had been checked from nine to four times only, February through the current date. The temperatures ranged from 150 degrees F to 160 degrees F.

Review, of the Physical Therapy Hydrocollator Equipment Policy # 4.11, last reviewed 4/12, with the Director of Rehab(ilitation), indicated the policy directed that the temperature of the Hydrocollator be maintained between 150-160 degrees F. Additionally the policy directed that the temperature be monitored daily. The Director of Rehab acknowledged the Hydrocollator temperatures had not been monitored per the policy.

f. During an interview, on 6/19/12 at 10:25 a.m., at an off-site Physical Therapy office, the Director of Rehab stated dirty linen was collected in bags in carts in the therapy rooms, the tops were tied and the bags stored in a back room until they could be transported to the hospital laundry by physical therapy staff. No laundry bags had been observed in back rooms earlier in the visit. Asked about the storage of clean linen, the Director of Rehab stated she had transported clean linen to the facility that morning but not yet brought it in. As the surveyor waited in the waiting room the Director of Rehab removed bags of dirty linen from a hall closet and then brought in clean linen wrapped in plastic and placed it on the shelves of the closet. The bags of dirty linen lay on the floor of the therapists' office in a mound.

Center for Disease Control Guidelines for Environmental Infection Control, 2003, pages 101 and 138, stated the following: "...Clean/sterile and contaminated
textiles should be transported from the laundry to the health-care facility in vehicles (e.g., trucks, vans,...) in vehicles that allow for separation of clean/sterile an contaminated items....
contaminated textiles may be transported in the same vehicle, provided that the use of physical barriers and/or space separation can be verified to be effective in protecting clean/sterile items from contamination."

g. During an observation, on 6/20/12 at 1:50 p.m., of the primary care clinic operated under the hospital license, two autoclaves sat on a counter to the left of one entrance to the "lab room". Office Manager Q, stated clinic staff used the autoclaves to sterilize reusable patient care instruments or podiatry surgical instruments. A log, titled Autoclave Cleaning Log, hung on the cupboard above the autoclaves. The cleaning log directed "*must be cleaned every two weeks".

Review, of the Autoclave Cleaning Log, with Office Manager Q, indicated Autoclave #1 had been cleaned 11/1/11, 01/09/12, 03/25/12, 05/17/12, 5/31/12 and 6/11/12. Autoclave #2 had been cleaned 10/17/11, 5/17/12, 5/31/12 and 6/11/12. Asked why the directions to clean every two weeks had not been followed, Office Manager Q stated they had trouble with one of the autoclaves # 2, earlier in the year so it had not been used or cleaned until it was fixed. It was pointed out that Autoclave # 1 had been in use, but had not been logged as cleaned every two weeks as directed.

Office Manager R replied that she had directed the staff to clean the autoclaves every two weeks because they were being used so much but the manufacturer's guidelines said the autoclaves should be cleaned monthly. It was pointed out that the log indicated neither autoclave had been cleaned in December 2011, or in February or April of 2012.

Review, of the manufacturer's guidelines for cleaning the autoclaves indicated the autoclave reservoir should be drained and the sterilizing chamber and instrument trays should be cleaned weekly with mild soap. The entire system should be flushed monthly with a sterilizer cleaner.

h.1. During observation of one out-patient laboratory draw station, on 6/19/12 at 9:45 a.m., Certified Laboratory Assistant P (CLA P) registered a patient at the front desk of the draw station. CLA P escorted the patient into the blood draw room, did some paperwork, then placed a tourniquet on the patients right arm. CLA P then palpated the patient's vein at the right antecubital area (area in front of the elbow), put on gloves, swabbed the area with an alcohol wipe, inserted the needle, withdrew blood and dropped the blood into a blood tube. CLA P then applied pressure to the area, and removed the tourniquet, instructed the patient to continue to apply pressure while he gathered a length of sticky gauze that he wrapped around the patients arm. CLA P labeled the tube and placed it into a rack on top of the refrigerator, and then discarded the gloves. CLA P then stepped into the hall demonstrate the location of the bathroom. Asked if the bathroom sink was the only sink to which he had access , CLA P said yes and then stepped back into the blood draw room and applied gel to his hands. CLA P had not washed or gelled his hands prior to donning gloves, nor after completing the procedure.


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h.2. Certified Lab Assistant (CLA) H accompanied a patient from the waiting room to Room 1, then sat at the desk in the room to enter information into a computer. CLA H donned a clean pair of gloves and proceeded to draw blood from the patient's left arm, labeled the specimen tube, and applied a dressing to the phlebotomy site. CLA H removed her gloves and walked out of the room to the front desk, then returned to the room. CLA H did not wash her hands or use hand sanitizer before donning gloves or after removing them at the end of the procedure.

During interview on 6/19/12 at 3:10 p.m., Lab Manager I stated proper hand hygiene for lab staff included washing hands before and after each patient procedure, after a specimen is handled, and before donning and after doffing gloves.

The facility's Infection Prevention policy and procedure number 2.05, titled "Hand Hygiene," last revised 1/10, indicated the following: "Decontaminating: when hands are not visibly soiled, an alcohol based hand rub should be used for routine degerming hands. 1. Before and after direct patient care 2. Before performing invasive procedures . . . 5. Before donning sterile gloves 6. After removing gloves".



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i. On 6/20/12 at 1:53 p.m. during an inspection of the Healdsburg Primary Care Clinic (HPC) the surveyor inspected the "laboratory" section of the HPC where blood samples were spun down in a centrifuge, urine samples were tested and where staff cleaned and sterilized contaminated medical instruments.

The surveyor noted a refrigerator under a "front" counter that staff identified as containing vaccines from the Vaccines for Children Program (VFCP) and on a wall opposite from that counter was a second refrigerator that also contained vaccines for use for the rest of the clinic patients. At the far left side of the "front" counter about three feet from the area under which the VFCP refrigerator was located, staff had placed a centrifuge to spin down blood samples so that blood cells could be separated from serum. Underneath the section of the counter on which the centrifuge was located, the surveyor noted staff had placed an emergency drug kit, the inspection of which later in the day indicated it contained injectable medications and other supplies used to treat medical emergencies. A sink was located in the "front" counter about three feet to the right of the area of the counter under which staff had located the VFCP refrigerator and to the right of the sink staff had placed two tubs, one of which contained medical instruments. Directly across from this area on the opposite wall was a "back" counter. The staff had placed a sign on the right end of this counter that read "Dirty" and to the right of that staff had placed a towel. In a small hallway next to the "back" counter, on the wall immediately adjacent to that counter, the surveyor inspected a cabinet that contained medications for use by the clinic patients.

During an interview of Manager R on 6/20/12 , she stated that HPC staff placed contaminated instruments into the tub located next to the sink on the "front" counter and which contained a multi-enzyme detergent. Then staff rinsed off the detergent soaked instruments in the sink, and if they had hinges, staff would then place the rinsed instruments in a second container next to the enzyme detergent container that Manager R stated contained a lubricant. All rinsed/lubricated instruments where then placed on the towel on the "back" counter to dry. Then staff would wrap the instruments in paper in preparation to autoclaved in one of two autoclaves located in an area labeled by staff as "clean" on the "back" counter.

While the surveyor inspected the laboratory, two different employees came in and tested patient urine samples using urine dipstick test (have patches that change color enabling staff to test the urine according to a diagram provided on the tube of dipsticks). One tested the urine sample on the section of the "front" counter directly above the VFCP refrigerator and a second employee did his urine dipstick test on the section of the "front" counter immediately to the right of the area under which the VFCP refrigerator was located. While the surveyor was inspecting a tray containing vaccines from the VFCP refrigerator, a third employee entered the laboratory space and stated she needed to administer a vaccine to a patient. The surveyor handed the vaccine tray to this employee, who removed a box of vaccines from the tray and then placed the tray containing the remaining vaccines on the "rear" counter to the right of the instrument drying towel on section that had the "Dirty" sign. Finally at 2:48 p.m., an HPC employee came in and used the centrifuge on the front counter to spin down a blood sample directly over the emergency drug supply.

On 6/21/12 at 9:37 a.m. during an interview of the hospital Infection Control Nurse (ICN), she stated the "clean" and "dirty" areas needed to be separate. She stated they needed to be visually and physically separated as much as possible. She stated that areas used for testing body fluids such as urine and blood should be physically separated from areas where drugs are prepared. She said that drugs always have to be in a clean area.

On 6/21/12 at 10:16 a.m. during an interview of the Director of Quality (DQ), she stated that storing medications in the HPC laboratory was an infection control problem.

On 6/21/12 at 10:34 a.m. the surveyor, the ICN, and the DQ all re-inspected the laboratory area of the HPC. Both the ICN and the DQ both agreed at that time that medications should not have been stored in that area of the HPC.

On 6/21/12 at 1:41 p.m. the surveyor re-inspected the laboratory area of the HPC and noted that staff had removed both vaccine refrigerators and all medications and the emergency medication supply from the laboratory area and relocated them in another room of the HPC.

Based on food service observations, dietary and nursing staff interview and dietary and medical record review the hospital failed to ensure the nutritional needs of patients were met as evidenced by: a) ineffective manual dishwashing of pots and pans; b) lack of effective sanitation for four of four facility ice machines; c) absence of an air gap (a gap between a food prep sink and the floor sink, to prevent sewage backflow) in dietetic departments' food production and manual dishwashing sinks as well as the kitchen and emergency rooms' ice machine; d) failure to follow the physician ordered diet for 1 patient (Patient 42); e) lack of a comprehensive nutritional analysis for the hospitals' commonly ordered diets and lack of a diet manual specific to the hospital's diets; f) inadequate food supply to be utilized in the event of a disaster; g) a meal delivery system that exposed uncovered foods to potential cross contamination; h) the retention of food production utensils that were cracked; i) lack of an effective system that monitored when potentially-hazardous foods (foods that require time/temperature control for safety to limit the growth of bacteria e.g. meat) were thawed; j) not following manufacturers' guidance for food storage; k) lack of timely assessment of 1 of 10 records reviewed for nutrition care (Patient 50); l) lack of a system to ensure availability of nutrition care 7 days/week and m) development of criteria for nutrition assessment based on staffing rather than patient acuity.

Failure to ensure the development of comprehensive food and nutrition services may result in practices associated putting patients at risk for food-borne illness, delivery of patient meal trays that did not meet physician orders, inadequate food supplies in the event of a disaster and lack of effective systems to ensure timely and effective nutrition interventions. These failures may put patients at risk for further compromising medical status.

Findings:

a) During dishwashing observations on 6/19/12 beginning at 10:20 a.m., Dietary Staff 2 (DS 2) was observed washing a cutting board that was used to cut vegetables. DS 2 was observed rinsing the board under running water and immersing it in a sanitizing solution. There was no washing with detergent or rinsing with water. In a follow up observation on 6/19/12 beginning at 10:35 a.m., DS 3 was observed washing pots and pans in the three-compartment sink whose length, width and depth was approximately 24 x 24 x 24 inches. There was no immersion of the pots during the washing process. Additionally the cooking sheets that measured approximately 3624 inches and were too large for the sink were not fully immersed in either the wash, rinse or sanitize steps. It would be the standard of practice to ensure that all items that were manually washed would be fully immersed in the detergent, rinse and sanitize steps (Food Code, 2009).

The facility policy, entitled, "Three Pot Sinks Washing and Sanitizing," dated 2/12, indicated to, "assure that pots and pans are washed and sanitized in a manner to ensure their safety for use in food production."

b) On 6/19/12 beginning at 10:45 a.m., the maintenance of the ice machines was reviewed with Engineering Staff (ES) 10. He described a process whereby he removed the internal parts of the ice producing mechanism and scrubbed them with a brush and rinsed them with water. ES 10 stated that there were a total of four ice machines and two different models. Review of manufacturers' guidance for both models of ice machines described either an annual or bi-annual (depending on the model) that included cleaning with a descaling chemical as well as sanitation using a 5.25% bleach solution. In a concurrent interview with ES 10 he acknowledged that he was not following the manufacturers' guidance.

c) During general kitchen observations on 6/19/12 beginning at 10:15 a.m., DS 2 was rinsing vegetables in the food production sink. It was noted that the sink did not have an air gap. Similarly it was also noted that there was no air gap in the 3-compartment sink. Additional observations on 6/20/12 beginning at 9 a.m., of the ice machine in the cafeteria and the emergency room revealed that while the condensation line of the ice machines was draining into a floor sink, the tube was placed inside the sink. It would be the standard of practice to ensure the presence of an air gap between the water supply inlet and the flood level rim of the plumbing fixture, equipment, or nonfood equipment and shall be at least twice the diameter of the water supply inlet and may not be less than 1 inch (Food Code, 2009).

d) During trayline observation on 6/19/12, beginning at 11:45 a.m.., it was noted that there was a physician ordered 2000 calorie American Diabetes Association (ADA) diet for Patient 42. It was also noted that the meal tray did not differ from other meal trays with physician-ordered regular diets. In a concurrent interview, the Registered Dietitian (RD) and the DS 1 were asked to describe how the diet would be implemented. They stated that the previous RD developed a chart that reflected the number of carbohydrates that would be included in each meal. The RD also stated that this chart would not allow one to determine the number of calories received either per meal and/or per day. The RD also stated that the facility did not have a nutritional analysis of the menus.

The provisions of the Dietary Reference Intakes (DRI), which included the Recommended Dietary Allowances (RDA's) Adequate Intake, and Acceptable Macronutrient Distribution Range, developed by the Food and Nutrition Board under the aegis of the Institute of Medicine, were used to evaluate nutritional adequacy of patient/resident menus. The hospital menus used were not evaluated for the complete array of macro and micro nutrients specified by the DRI.

e) In an interview on 6/19/12, beginning at 11:45 a.m., the RD stated that she recently joined the hospital as an employee, and that the hospital was using the American Dietetic Association Nutrition Care Manual as a diet manual (referenced in the facility, "Diet Manual," policy, last reviewed 2/12. Comparison of the nutrition care manual on 6/20/12, beginning at 10:30 a.m., with the RD, revealed that the Nutrition Care Manual (NCM) was a conceptual description of diets rather than a diet manual. A diet manual would ensure that the diets offered met the current standards of practice; would include a comprehensive description of the therapeutic diets offered by including the purpose of the diet, the indications of the diet, the nutritional adequacy, sample meal plans consistent with the hospital's menu, and standard of practice references for the diets. It was also noted that, with the exception of the carbohydrate crosswalk, there was no other guidance specific to the hospital's menus that provided guidance for physicians ordering the diets, for the nurses who facilitated implementation of the diets and dietary staff who prepared the diets. While the NCM had some of the elements, not all elements were present for each routinely-ordered hospital diet, that would allow for hospital and/or dietary staff to use the document, as a comprehensive resource, to order and/or prepare patient diets.

f) On 6/19/12 beginning at 1:30 p.m., disaster meal preparedness was reviewed with the RD and DS 1. It was noted that the hospital had stored food supply that consisted primarily of dried and canned goods. In a concurrent interview the RD and DS 1 were asked to describe the minimum level of food required to implement the disaster menu. They stated that the previous RD prepared an inventory however they were unsure of food on hand based on the developed menu. Concurrent review of the document revealed that the hospital was planning for 75 patients and staff in the event of an emergency. In a follow up interview on 6/21/12 beginning at 9:30 a.m., the RD stated that after reviewing the hospitals' staffing it would likely require 125 staff members to implement the plan for the licensed bed count of 25 for a total of 150 persons. The RD also acknowledged that the disaster plan required additional work to ensure effective implementation.

g) During meal delivery observation on 6/20/12 beginning at 12:45 p.m., it was noted that it was the responsibility of nursing staff to deliver patient meal trays. It was also noted that for this meal the dessert was a slice of pie which was uncovered. Nursing staff was observed removing the tray from the meal cart and distributing the meals to patient rooms which ranged from approximately 10-65 feet. It would be the standard of practice to ensure that patient meals were distributed in a manner to prevent cross-contamination. Uncovered foods may be susceptible to cross-contamination from airborne pathogens (Food Code, 2009).

h) During general kitchen observations on 6/19/12 beginning at 8:30 a.m., it was noted that there were greater than six knives with handles that were worn. It was also noted that these handles had cracks and were sticky to the touch. In a concurrent interview DS 1 stated that in the past she tried to clean the knife handles; however stated that the plastic handle was beginning to break down causing the cracks and stickiness. It would be the standard of practice to discard items whose integrity, such as the cracks and stickiness, was compromised (Food Code, 2009).

i) During initial tour on 6/19/12 beginning at 9:30 a.m. in the walk-in refrigerator there were two packages of ground beef that were fully thawed. It was also noted that that there was no thaw date; however there was a tag that indicated, "use thrs [Thursday]," which was 6/21 (three days after removal from the freezer). In a concurrent interview DS 1 stated that while staff routinely used the refrigerator to thaw meats, they did not indicate the date the item was pulled from the freezer. She also stated to her knowledge the hamburger was likely pulled on 6/18/12. In a concurrent interview with the Registered Dietitian she acknowledged that without dating it would be difficult to ensure that thawed meats were not held for extended periods of time. Departmental policy 2.06 titled "Food Safety," last reviewed 2/12, guided staff to thaw frozen foods 2 days before use. Review of un-referenced and undated hospital document titled "Storing Foods in Refrigerator and Freezer" noted that ground meat would be held in the refrigerator 1-2 days.

j) During initial tour on 6/19/12 beginning at 9:30 a.m., it was noted that in the walk in refrigerator staff failed to store foods according to manufacturers' guidance. It was noted that there were vegetarian burger patties with manufacturers' guidance to "keep frozen." Similarly there was also a case of various loafs of bread in the freezer. In a concurrent interview, Dietary Staff 1 stated that this was the normal storage practices for these items. Review of un-referenced and undated hospital document titled "Storing Foods in Refrigerator and Freezer" noted that bread should not be stored in the refrigerator as it accelerated the rate of spoilage.

k) Patient 50 was admitted with diagnosis including respiratory failure and pulmonary (lung) disease. A history and physical dated 8/18/11, noted the patient was being admitted with a Stage III pressure ulcer. A Stage III pressure ulcer is described as full thickness tissue loss. Subcutaneous (beneath the skin) fat may be visible but bone, tendon or muscles are not exposed; may include undermining and tunneling (National Pressure Ulcer Advisory Panel, 2007). Admission weight was 127 pounds and height was 5 feet 5-1/2 inches.

A comprehensive nursing admission assessment dated 8/11/11, failed to notify the RD of the presence of the wound at the time of admission which resulted in a delay of the nutrition assessment.

A nursing flow sheet dated 8/22/11 noted that the, "RD was notified," of the patients' pressure ulcer. A nutrition assessment completed on 8/22/11 (11 days after admission) by the RD noted that the patient had a decreased albumin level on 8/19/11 of 2.4 gm/dl (grams per deciliter--a measurement--normal 3.5-5.0 gm/dl). Albumin is a measure of protein stores. Protein is an integral component in wound healing (National Pressure Ulcer Advisory Panel, 2009). The assessment also noted that the patient "likely" had inadequate dietary intake as well as a recommendation to encourage increased protein consumption; however there was no intervention how the patient would receive increased protein during hospitalization taking into consideration the RD indicated that the patients intake was likely adequate.

Review of the undated hospital policy titled "Nutrition Screening, Assessment and Follow Up" noted that patients with pressure ulcers were considered to be at high nutritional risk. Lack of timely notification to the RD of nutrition risk resulted in a delay in nutrition assessment. Lack of development of nutrition interventions to increase Patient 50's protein intake may result in not meeting patient nutritional needs for effective wound healing.

l) In an interview on 6/19/12 beginning at 10 a.m., the RD was asked to describe the organizational structure of the department. She stated that it was her position that was empowered with providing managerial guidance to dietetic services. In addition she stated she was responsible for providing clinical nutrition care to inpatients. She additionally stated that there was a second part time RD who provided clinical nutrition care to the separately licensed affiliated skilled nursing facility. The surveyor asked the RD to describe the process for weekend coverage at the general acute care hospital. She stated that currently there was no scheduled coverage or formal mechanism to ensure nutritional needs of inpatients were met 7 days/week.

m) In a concurrent interview the surveyor asked the RD to describe how the frequency of nutrition assessments was determined. She replied that currently the hospital had a policy that ensured that patients were seen within 72 hours of admission regardless of their nutritional risk. She further stated that she was unsure of the standard of practice that was used as the basis of the policy development; however also stated that it was likely developed based on staffing rather than nutritional acuity of patients. In a follow up interview on 6/20/12 beginning at 9:30 a.m., the RD stated that the current average length of stay was 3.8 days. She also acknowledged that a policy whereby patients may wait three days for a nutrition assessment may not meet patient nutritional needs, nor allow opportunities for timely nutrition intervention, in particular since the average length of stay was slightly greater than three days.

Based on medical record review and Registered Dietitian (RD) interview, the hospital failed to ensure 2 of 10 patients reviewed for nutrition care (Patients 43 and 50) were referred to the RD in a timely manner . Failure to ensure timely nutrition care may result in increased length or hospitalization and further compromise patients' medical status.

Findings:

Patient 43 was admitted with diagnosis including diabetic ketoacidosis (a severe elevation in blood sugar). A history and physical dated 6/15/12, noted that the patient was experiencing poor dietary intake for several days and had diarrhea. Admission lab work dated 6/15/12, noted a blood glucose value of 968 mg/dl (milligrams per deciliter, a measurement--normal 70-110 mg/dl) and albumin (a measure of protein stores) was 2.2 gm/dl (grams per deciliter, a measurement--normal 3.5-5.0 gm/dl). Nursing admission assessment dated 6/16/12, failed to note the loss of appetite on the admission screening. The document did however note that the patient had diabetes; however there was no indication that the patient was referred to the RD. In an interview with the RD on 6/21/12 beginning at 9 a.m., she stated that patients who were experiencing poor dietary intake would be considered at nutritional risk and should have been referred to the RD.

The hospital policy entitled, "Nutritional Screening, Assessment and Follow-Up," revised 2/12, indicated that those patients identified as being at nutritional risk will be assessed by the Registered Dietician to determine their nutritional care needs.

Patient 50 was admitted with diagnosis including respiratory (breathing) failure and pulmonary (lung) disease. A history and physical dated 8/18/11 noted the patient was being admitted with a Stage III pressure ulcer. A Stage III pressure ulcer is described as full thickness tissue loss. Subcutaneous (beneath the skin) fat may be visible but bone, tendon or muscles are not exposed; may include undermining and tunneling (National Pressure Ulcer Advisory Panel, 2007). Review of hospital document titled "Pressure Sore/Wound Care Flowsheet" documented the wound as an excoriated coccyx (abrasion of the skin in the area at the base of the spine) and noted it as a Stage I pressure ulcer. It was also noted that no wound measurements were taken. In an interview and concurrent medical record review on 6/21/12 beginning at 1:15 p.m., RN 11 stated that it would be the standard of practice within the hospital to ensure all wounds were measured. She also stated that based on the picture taken of the buttocks there appeared to be an open would over the coccyx and appeared to be more than excoriation and acknowledged that no measurements were documented on the flow sheet.

Hospital policy titled, "Skin Risk Evaluation Skin Care Protocol," dated 3/12, noted that "1. The condition of the patient's skin must be assessed at the time of admission ...and carefully document on the Nursing Admission Assessment form." Hospital document dated 5/28/09 and titled "Pressure Sore/Wound Care Flowsheet" guided staff to document the size of patient wounds.

Based on interview and record review, the facility failed to obtain timely authentication of telephone physician orders for two patients (Patients 43 and 44), when: 1. Telephone orders for Patient 43, received and written in the patient's clinical record from 6/16/12 to 6/18/12, had not been countersigned by a physician within 48 hours; and 2. Telephone orders for Patient 44 from 6/15/12 through 6/16/12 had not been cosigned by a physician.

This failure had potential to result in miscommunication and errors regarding medications and/or other care and treatment orders, and adversely affect the safety and well-being of patients.

Findings:

1. Patient 43's clinical record was reviewed on 6/18/12, and indicated the patient was admitted to the Intensive Care Unit (ICU) on 6/16/12. Multiple telephone orders, written from admission on 6/16/12 to 6/18/12, had not been countersigned by a physician as follows:
6/16/12 at 5 a.m. 6/17/12 at 1:45 a.m.
6/16/12 at 9:15 a.m. 6/17/12 at 8:15 a.m
6/16/12 at 2:15 p.m. 6/17/12 at 9:15 a.m.
6/16/12 at 4:30 p.m. 7/17/12 at 11:30 a.m.
6/16/12 at 6:30 p.m 6/17/12 at 9 p.m.
6/16/12 at 7:30 p.m. 6/17/12 at 10:30 p.m.
6/16/12 at 9 p.m. 6/18/12 at 12:50 a.m.
6/16/12 at 10:45 p.m.
6/16/12 at 11:25 p.m.

During subsequent record review on 6/19/12 at 9:45 a.m., the telephone orders remained unauthenticated.

During interview on 6/19/12 at 9:45 a.m., RN J stated nursing staff was not supposed to take verbal orders from physicians. Telephone orders with "read back" were acceptable for nursing staff to take, and physicians were supposed to countersign their verbal and telephone orders within 24 hours.

During interview on 6/21/12 at 3:30 p.m., Director Inpatient Services (Director) K stated it was the facility's practice for physicians to countersign their telephone orders within 24 hours.

The facility's policy and procedure, titled "Verbal Orders," last reviewed 4/12, indicated the following: "4. Verbal orders must be countersigned, dated and timed by the prescribing physician within forty-eight (48) hours."


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2. During a review, on 6/18/12 at 3:45 p.m., of the clinical record for Patient 44, eight pages of verbal and telephone orders dated 6/15/12 at 2015 (8:15 p.m.) through 6/16/12 at 1810, (6:10 p.m.) had not been cosigned by a physician. The orders included Insulin, (used to control high blood sugar), and Heparin, ( used to thin blood to prevent clots), both identified as High Alert Medications by the Institute of Safe Medication Practices due to the increased risk of significant patient harm if used in error.

An telephone order, dated 6/16/12 at 1450, (2:50 p.m.), included the direction, "(change) pt (patient) to DNR", (Do Not Resuscitate)". The order was read back to the physician but signed by only one registered nurse.

Located at the front of the clinical record was a laminated notice addressed to the physician which stated, orders require your signature within 48 hours.

Copies of the order pages were obtained on 6/19/12 at 11:50 a.m. The orders had not been cosigned by a physician. Case Manager S verified that the order pages did not have a physician signiture.

Review, on 6/19/12 at 2:45 p.m., of Pharmacy Policy #10.03, Orders Verbal, revealed: "Medications or biologicals must be authenticated within 48 hours....DNR must be witnessed by 2 registered nurses and authenticated with 24 hours".

Based on interview, medical record review, and document review, the hospital failed to ensure that each surgical patient's preoperative record included a pertinent medical history and assessment of health status, with the potential result of patient injury.

Findings:

On 6/11 and 6/12/12, review of 22 closed medical records of patients who had undergone surgery demonstrated that the records of Patient 56 and Patient 57 did not contain current (within 30 days prior to surgery) comprehensive medical history and physical assessment [H&P] reports).

Patient 56's record documented that he underwent a surgical procedure on 5/17/12. The short form H&P signed by Physician EE on 5/17/12 was absent past medical and surgical history except for mention of an epidural steroid injection in March 2012. The H&P was also absent documentation of review of systems, family and social history, current medications, allergies, vital signs, and ASA classification (estimate of ability to tolerate anesthesia).

Patient 57's record documented that he underwent a surgical procedure on 4/2/12. The H&P dictated by Physician FF on 3/27/12 was absent past medical history, review of systems, family and social history, current medications, allergies, vital signs, and physical assessment other than examination of the extremities. Physician EE stated that Patient 57's H&P would be provided by his primary care physician (PCP), but the PCP's report was not in the medical record.

On 6/13/12, review of hospital policy "Pre-operative history and physical/Routine Pre-operative Lab Work," last reviewed 3/12, demonstrated it included the requirement that "a complete history and physical examination will be hand written or dictated and transcribed prior to surgery."

Based on interview and document review, the hospital failed to ensure the effectiveness of its quality assurance program when:

1. The Quality Committee did not follow the guidelines of the hospital's quality assurance program (See C 336).

2. The hospital failed to ensure food and nutrition services developed a quality assurance program that demonstrated opportunities for improvement.
(See C 337).

3. The Quality Committee failed to identify opportunities for performance improvement in infection control. (See C 338).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective quality assurance program for evaluation of patient care services, including food services and infection control, and development, implementation and evaluation of effective corrective actions for program improvement.

Based on interview and document review, the hospital failed to ensure the effectiveness of its quality assurance program in that the Quality Council (a committee of the medical staff with members appointed to oversee all performance improvement activities of the hospital) did not function in accordance with the requirements of the hospital's bylaws, which mandated that the Council meet at least quarterly and consist of at least four members of the active medical staff, including the chief of staff, plus a member of the board of directors and the chief executive officer, as voting members. The failure to meet quarterly and the failure of a quorum of the voting members to attend the two meetings held in the twelve months prior to the survey, potentially resulted in delay in the assessment of issues integral to the improvement of care and services.

Findings:

Document review on 6/19/12, demonstrated that the hospital medical staff bylaws mandated that the Quality Council (Section 10.7-1) shall be an interdisciplinary committee of the medical staff consisting of at least four members of the active medical staff, including the chief of staff. In addition, members shall include a representative of the board of directors and the chief executive officer. Non-voting members of the Council included the chief nursing officer, the quality improvement coordinator, and two hospital managers. Bylaws Section 10.7-3, indicated that the Quality Council should meet as often as necessary, but at least quarterly.

On 6/20/12, review of the Quality Council minutes for the twelve months prior to the survey, demonstrated that the council met on 8/16/11 and 3/20/12. Of the six active medical staff members listed as expected attendees, Physicians HH, II, JJ, and LL were listed as absent without excuse. Also absent without excuse were CEO and CNO. Review of the 3/20/12, minutes demonstrated that Physician GG, the committee chairman, and Physician JJ attended. CNO and CEO did not attend. A quorum of voting members was not available for either meeting.

In interview on 6/20/12 at 10 am, the Director of Quality acknowledged that the Quality Council did not meet the frequency and attendance requirements mandated by the hospital bylaws. She stated that one of the meetings had been cancelled due to the death of the committee's governing board member.

Based on dietary staff interview and performance improvement document review, the hospital failed to ensure food and nutrition services developed a quality assurance program that demonstrated opportunities for improvement, with the potential for lack of identifying opportunities for future improvement.

Findings:

On 6/21/12 beginning at 11 a.m., performance improvement activities for food and nutrition services were reviewed with the Registered Dietitian (RD). The hospital presented activities for 2011 and 2012. It was noted that the reviewed quality indicators included patient assessment (nutrition risk screening, nutrition and assessment of high risk patients), and quality control that included accuracy/appearance/temperature of trays as well as food storage quality control that included refrigerator/freezer temperatures and labeling/dating of stored and thawing foods. It was noted that the department achieved a success rate of greater than 98% on all of the measured parameters. In a concurrent interview with the RD she acknowledged that while these were important activities to the department they did not reflect opportunities for improvement.

Review of hospital document titled "Performance Improvement Plan 2012" noted that the purpose of the performance improvement program was to provide a " ...systematic, coordinated and continuous approach to improving care and services ... ".

Based on interview, and review of hospital documents, the hospital failed to develop a quality assurance plan that identified corrective actions for an increase in hospital acquired and surgical site infections, with the potential that the increase infection rate would continue.

Findings:

During an interview, on 6/21/12 at 3:40 p.m., the Infection Preventionist stated the hospital Infection Log was complete through November 2011. The Infection Preventivist stated she had recently assumed the infection control position and was reviewing data from October, 2011 forward to gather statistics on healthcare acquired infections, (HAI), and surgical site infections.

The Infection Preventionist stated the hospital had four surgical site infections from June 2011 through October 2011, and reviewed each infection, including infections with organisms pseudomonas, e. coli, and Methicillin resistant staph aureus. (MRSA). All were reported to the National Nosocomial Infection Surveillance System, a program of the Center for Disease Control National Health Care Safety Network

During an interview, on 6/21/12 at 1:55 p.m., the Director of Perioperative Services stated he did a monthly review of quality indicators in the perioperative area, including documentation of patient's pain scales, completeness of operative permits, and administration of preoperative antibiotics within a specified time frame. The quality indicators did not address surgical site infections.

A concurrent review, of OPD/PACU (Outpatient Department/Post-Anesthesia Care Unit) Performance Measurement Report, dated 2012, indicated quality indicators had been reviewed January through March 2012, no results were recorded for April or May 2012.

The Director of Perioperative Services stated he reported the Perioperative Performance Measurement Report to the quarterly Surgical Services Section meeting, and sent a copy to the hospital risk management department.

Review of a Performance Improvement Report to the most recent Quality Council Committee meeting in March, 2012, indicated healthcare acquired infections had increased from an overall rate of 13.8 (per 1000 patient days) in 2010 to 19.7, 8.2 and 9.1 respectively in the first three quarters of 2011. Further statistics for the last quarter of 2011 and the first two quarters of 2012 were unavailable.

The Performance Improvement Report indicated surgical site infections had increased from a total of 0.63 per 100 procedures in 2010, to 2.56, 1.7 and 1.09 in the first three quarters of 2011. As with hospital acquired infections, no additional statistics were available.

The Performance Improvement Report indicated a physician had agreed to be on the hospital Infection Prevention Committee beginning in 2012, as an action to address the increased HAI rate, however no action was specified to address the increased surgical site infection rate.

Review, of the hospital Performance Improvement Plan for 2012, revised 3/12, indicated the Quality Council was responsible to oversee all all performance improvement activities in the hospital, including identifying opportunities for improvement.