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Based on review of facility documents, The Bylaws of The Medical Staff, and staff interview (EMP), it was determined that the facility failed to ensure that physician documentation reflected a discussion with the patient and/or family regarding a patients code status for two of three applicable medical records reviewed (MR17 and MR20).

Findings include:

Review on January 31, 2012, of the "Bylaws of the Medical Staff Schuylkill Medical Center South Jackson Street," last revised 2011, revealed "Preamble ... Article II - Medical Staff Membership ... Section 5 - Responsibilities of Medical Staff Membership Each member of the medical Staff shall: ... abide by the medical Staff Bylaws and by all other lawful standards, policies and rules of the Medical Staff and the Hospital ..."

Review on January 31, 2012, of the facility's "Code Blue Physician Order" policy, last approved January 9, 2012, revealed "Policy: To establish code Blue options for the physician to direct staff in providing resuscitative measures for the patient. Procedure: ... D. Option #4 Do Not Resuscitate D.N.R. 1). Considerations relevant to the D.N.R. decision will be listed on the record by the physician. The physician will list factors or considerations relevant to the D.N.R. Decision. 2). Patient Competence: The physician will determine patient competency and check the appropriate space to indicate competent or incompetent. ... F. Persons participating in the D.N.R. Decision: The physician will list the name and relationship of any person or family member involved in the D.N.R. decision and the date of discussion when the patient is unable to make the decision (incompetent). ..."

Review on January 31, 2012, of the facility's "Code Blue Physician's Orders," last revised November 2010, revealed an area labeled Patient is Competent: Yes No Persons Participation in the Code Status Decision Name Relationship to Patient Date for the physician to complete.

Review on January 31, 2012, of MR17 revealed the patient's physician ordered D.N.R. (Do Not Resuscitate) status on this patient on December 6, 2011. Further review of MR17 revealed no documented discussion with MR17 or MR17's family regarding their participation in this patient's code status decision.

Review on January 31, 2012, of MR20 revealed the patient's physician ordered D.N.R. status on this patient on December 15, 2011. Further review of MR20 revealed the patient's physician changed MR20's code status to a full code on December 21, 2011. MR20's medical record did not contain documented discussion with MR20 or MR20's family regarding this patient's code status decision or the change in MR20's code status from a D.N.R. to a full code.

Interview with EMP3, EMP12 and EMP13 on January 31, 2012, at approximately 12:15 PM confirmed MR17 and MR20 did not contain documentation of discussion with the patients (MR17 and MR20) or documentation of discussion with MR17 and MR20's family regarding the patients' code status.

Based on review of facility documents, credential files (CF) and staff interview (EMP), it was determined that the facility failed to follow the Bylaws of the Medical Staff for one of 15 credential files reviewed (CF9).

Findings include:

Review on June 15, 2009, of the "Bylaws of the Medical Staff Schuylkill Medical Center South Jackson Street," last reviewed 2011, revealed "Article VIII - Corrective Action and Suspension ... Section 4 - Automatic Suspension ... 4.4 Malpractice Insurance - The clinical privileges of a practitioner shall be automatically suspended if such practitioner fails to maintain the required amount of professional liability insurance after being informed in writing of this requirement. ..."

On January 30, 2012, the facility provided a listing of all medical staff. From the listing of medical staff, 15 credential files (CF) were randomly chosen for review.

Review of CF9 on January 30, 2012, revealed the physician's credential file did not contain evidence of current malpractice insurance.

Review on January 30, 2012, of the facility's Work Status Report for CF9 revealed this physician worked in the facility on January 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 17, 19, 20, 21, 22, 23, 24, 26, 27, 28, 29 and 30, 2012.

Interview with EMP4 on January 30, 2012, at approximately 1:15 PM confirmed CF9's credential file did not contain evidence of current malpractice insurance and that CF9 worked on the above listed dates.

Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure nursing reassessments were conducted following the administration of pain medications for two of five applicable medical records reviewed (MR13 and MR16).

Findings include:

Review on January 31, 2012, of the facility's "Guidelines For: Pain Assessment Flow Sheet" policy, last revised November 2010, revealed "Policy: A Pain Assessment Flow Sheet will be initiated by an RN, GN, or LPN on all patients who experience acute or chronic, on-going or recurrent pain. Procedure: 1. Patients will be assessed for presence or absence of pain each shift or more frequently as the patient condition warrants, the RN/GN as appropriate. ... Reassessment: Reassess the patient within 60 minutes or more frequently as appropriate for effectiveness of analgesia/treatment for pain. Document the pain score as indicated by the patient's rating of his/her pain on the bottom of the flow chart in the designated area for reassessment. Nurse's Notes: Document any other information regarding the patient's assessment of his/her pain experience, or any of the nursing assessments relating to pain not already addressed. ..."

1) Review on January 31, 2012, of MR13 revealed the patient's physician ordered Morphine Sulfate (a narcotic pain medication) 5 milligrams (mg) intravenously (IV) every four hours as needed for pain; Tramadol (a narcotic pain medication) 37.5/325 mg PO (orally) every six hours as needed for pain; and Morphine Sulfate 8 mg IV every two hours as needed for severe pain.

Review on January 31, 2012, of MR13's medication administration record (MAR) revealed nursing staff administered Morphine Sulfate 5 mg IV on January 28, 2012, at 1:57 PM and on January 29, 2012, at 10:43 AM and 1:05 PM. Further review of MR13 revealed no documentation that nursing staff reassessed this patient's pain level following the administration of the Morphine Sulfate 5 mg IV on January 28, 2012, and January 29, 2012.

Review on January 31, 2012, of MR13's MAR revealed nursing staff administered Tramadol 37.5/325 PO to MR13 on January 28, 2012, at 1:28 PM. Further review of MR13's medical record revealed no documentation that nursing staff reassessed this patient's pain level following the administration of Tramadol 37.5/325 PO on January 28, 2012.

Review on January 31, 2012, of MR13's MAR revealed nursing staff administered Morphine Sulfate 8 mg IV on January 29, 2012, at 8:20 PM. Further review of MR13's medical record revealed no documentation that nursing staff reassessed this patient's pain level following the administration of Morphine Sulfate 8 mg IV on January 29, 2012.

2) Review on January 31, 2012, of MR16 revealed the physician ordered Vicodin (a narcotic pain medication) 7.5/500 mg, one to two tablets PO every four hours as needed for pain. Review of MR16 revealed nursing staff administered Vicodin 7.5/500 orally to this patient on December 6, 2011, at 4:56 PM with a documented reassessment at 6:30 PM. Further review of MR16 revealed no documentation that nursing staff assessed MR16's pain level within 60 minutes of administering Vicodin to the patient on December 6, 2011, as per facility policy.

Interview with EMP3, EMP12 and EMP13 on January 31, 2012, at approximately 11:45 AM confirmed nursing staff administered pain medication to MR13 and MR16. EMP3, EMP12 and EMP13 confirmed nursing staff did not reassess MR13's pain level following the administration of Morphine Sulfate and Tramadol. Further interview with EMP3, EMP12 and EMP13 confirmed that nursing staff did not reassess MR16's pain level within 60 minutes following the administration of Vicodin.

Based on review of facility documents, medical records (MR) and staff interview (EMP) it was determined that the facility failed to ensure that all verbal orders were dated, timed, and authenticated by the ordering physician for five of five medical records reviewed (MR14, MR18, MR47, MR58, and MR59) and failed to ensure orders clarified by a pharmacist were signed, dated and timed by the ordering physician for three of three applicable medical records reviewed (MR12, MR58, and MR59).

Findings include:

Review on January 31, 2012, of the "Schuylkill Medical Center South Jackson Street Medical Staff Rules and Regulations," last reviewed 2011, revealed "... Section 6 - Medical Records ... 6.6 Doctor's Orders: 6.6.1 Verbal/telephone orders for medication or treatment shall be accepted only under urgent circumstances when it is impractical for such orders to be given in a written manner by the responsible practitioner. ... The orders shall included the date, time and full signature of the person taking the order and shall be countersigned, dated and timed within 24 hours by a practitioner. ..."

Review on January 31, 2012, of the facility's "Medication Ordering" policy, last reviewed October 2010, revealed "Policy ... 3. Telephone orders shall be accepted by the professional nurse only under urgent circumstances when it is impractical for such orders to be given in a written manner by the authorized prescriber. The prescriber shall countersign the order(s) within a 24-hour time period. ..."

1) Review on January 31, 2012, of MR14 revealed the physician gave verbal orders on January 27, 2012, for nursing staff to administer Valproic Acid (a medication used to treat seizures and migraine headaches) 1000 milligrams (mg) intravenously (IV) over 30 minutes and may repeat once; Dilantin level in AM; and Valproic acid level in AM. Further review of MR14 revealed the ordering physician did not sign, date or time the verbal orders.

Review on January 31, 2012, of MR14 revealed the physician gave verbal orders on January 28, 2012, for nursing staff to administer Valium 2 mg IV every six hours as needed; to insert a Foley catheter (a tube into the bladder) for accurate intake and output; to administer Cerebryx (a medication used to control seizures) 500 mg IV now over 15 minutes; to increase Dilantin to 200 mg PO BID (twice a day) and if not able to take orally to give Cerebryx 200 mg IV BID; a Valproic acid level and a Dilantin level in the morning; and an EEG (electroencephalogram - a test to record the electrical activity of the brain) in the morning. Further review of MR14 revealed the ordering physician did not sign, date or time the verbal orders.

Interview with EMP12 and EMP13 on January 31, 2012, at approximately 9:00 AM confirmed the physician did not sign, date or time the verbal orders given to nursing staff for MR14.

2) Review on January 31, 2012, of MR18 revealed the physician gave verbal orders on December 7, 2011, for nursing staff to consult physical and occupational therapy; and on December 11, 2011, for nursing staff to obtain urine for culture and sensitivity. Further review of MR14 revealed the ordering physician did not sign, date or time the verbal orders.

Interview with EMP13 on January 31, 2012, at approximately 10:00 AM confirmed the physician did not sign, date or time the verbal orders given to nursing staff for this patient.

3) Review on January 31, 2012, of MR47 revealed the physician gave verbal orders on January 2, 2012, for nursing staff to administer nasal O2 (oxygen) 2 liters/minute post-op, continuous pulse oximetry to maintain O2 sat (saturation) 92% or higher. The physician also gave verbal orders on January 27, 2012, for nursing staff to administer Atenolol (a heart medication)100 mg po (orally) daily- give dose at 5:00 PM tonight - hold for heart rate below 60, in AM start Prinivil (heart medication) 20 mg po daily, and Norvasc 5 mg po daily-hold for systolic blood pressure below 120. Further review of MR47 revealed the physicians did not sign, date or time the verbal orders given to nursing staff for MR47.

Interview with EMP20 at 11:40 AM on January 31, 2012, confirmed the physicians did not sign, date or time the verbal orders given to nursing staff for MR47.

4) Review on February 1, 2012, of MR58 revealed the physician gave verbal orders on May 20, 2011, for nursing staff to repeat K-dur (used to treat low potassium) 40 mg po now. Further review of MR58 revealed the physician did not sign, date or time the verbal orders given to nursing staff for this patient.

5) Review on February 1, 2012, of MR59 revealed the physician gave verbal orders on August 5, 2011, for nursing staff to discontinue Morphine (narcotic pain medication), administer Benadryl 25 mg IV now and Q (every) 8 hours PRN, and Demerol (narcotic pain medication) 25 mg IM Q 4 hours PRN pain. Further review of MR59 revealed the ordering physicians did not sign, date or time the verbal orders.

Interview with EMP2 at 2:45 PM on February 1, 2012, confirmed the physicians did not sign, date or time the verbal orders given to nursing staff for MR58 and MR59.

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Review on January 31, 2012, of the facility's "Pharmacy Clarification of Medication Orders" policy, reviewed April 2009 and October 2010, revealed "Purpose Reasons for pharmacist's clarification of medication orders are as follows: ... 2. Adjustment of Dosage. ... Policy 1. The pharmacist shall be responsible for contacting the appropriate physician or prescriber of medications if a problem is identified with drug therapy, a product is unavailable, or an order is unclear. 2. A pharmacist will discuss order clarifications with the responsible physician or prescriber. 3. All alterations or changes of medication orders arising out of such pharmacist/prescriber discussion will be documented on the 'Alteration or change of medication Order' form. .."

1) Review on January 31, 2012, of MR12 that the physician ordered Zosyn (an antibiotic) 3.375 Grams (gm) Intravenously (IV) every six hours.

Review on January 31, 2012, of MR12's Alteration or Change of Medication Orders revealed the pharmacist changed MR12's dose of Zosyn to 2.25 gm IV every 8 hours based on MR12's laboratory results. Further review of MR12 revealed no documentation the pharmacist consulted the patient's ordering physician regarding the change in dosing or that MR12's physician signed, dated, or timed the order change.

Interview with EMP3 on January 31, 2012, at approximately 10:00 AM confirmed the pharmacist changed MR12's Zosyn dose, and there was no documentation in MR12 indicating the patient's physician was consulted regarding the change in the Zosyn dosage.

2) Review on February 1, 2012, of MR59 revealed the physician ordered Zosyn 3.375 gm IV every 8 hours.

Review on February 1, 2012, of MR59's Alteration or Change of Medication Orders revealed the pharmacist changed MR59's dose of Zosyn to 3.35 gm IV every 6 hours based on MR59's laboratory results. Further review of MR59 revealed no documentation the pharmacist consulted the ordering physician regarding the change in dosing or that MR59's physician signed, dated, or timed the order change.

Interview with EMP2 on February 11, 2012, at approximately 9:00 AM confirmed the pharmacist changed MR59's Zosyn dose, and there was no documentation in MR59 indicating the physician was consulted regarding the change in the Zosyn dosage.

Based on review of facility documents, the Bylaws of the Medical Staff, and staff interview (EMP), it was determined the pharmacist failed to ensure the Medical Executive Committee approved a policy change regarding the administration of pain medications prior to the Pharmacy implementation.

Findings include:

Review on January 31, 2012, of the facility's "Bylaws of the Medical Staff Schuylkill Medical Center South Jackson Street," last revised 2011 revealed "... Part 4 Individual Committee Composition, Responsibilities and Functions ... 4.7 Pharmacy and Therapeutics Committee ... 4.72 Duties - This committee shall: ... Make recommendations regarding proper procedures and policies on the administration of drugs ... 4.73 Meetings - The Pharmacy and Therapeutics committee shall hold monthly meetings, but no less than ten (10) per year. The committee will report findings to the Executive Committee. All pharmaceutical, therapeutic, and formulary rules and regulations are to be approved by the Executive Committee. ..."

Review on January 31, 2012, of the facility's "Medication Ordering" policy, reviewed April 2009 and October 2010, revealed "Policy ... 10. ... Pain Meds ... Range orders (1-2 tabs) unless qualified will be automatically converted to 1 tab; may repeat in 30 minutes if no relief. ..."

Review on January 31, 2012, of MR16 revealed the physician ordered Lortab (a narcotic pain medication) 7.5/500 milligram (mg) one to two tablets PO orally every four hours as needed for pain.

Review on January 31, 20121, of MR16's medication administration record (MAR) revealed the pharmacy documented Vicodin (a narcotic pain medication) 7.5/500 mg PO every four hours may repeat again in 30 minutes. Interview with EMP6 revealed that Lortab and Vicodin were the same narcotic pain medication.

Review on January 31, 2012, of the facility's Medical Executive Committee meeting minutes for May 15 and June 18, 2009, revealed no documentation the Pharmacy and Therapeutics Committee approved changes for the Medication Ordering policy to include pain medication range orders that 1 - 2 tablets would automatically be converted to 1 tablet and may repeat again in 30 minutes.

Interview with EMP2, EMP3 and EMP6 on January 31, 2012, at approximately 3:30 PM confirmed changes to physician medication ordering discussed at the Pharmacy and Therapeutics Committee were to be presented to the Medical Executive Committee for approval. EMP2 and EMP6 confirmed the Medication Ordering policy change to include pain medication range orders of 1 - 2 tablets to be automatically converted to 1 tablet and may repeat again in 30 minutes if no relief was discussed at the April 2009 Pharmacy and Therapeutics committee. Further interview with EMP2 and EMP6 confirmed there was no documentation in the Medical Executive Committee meeting minutes for May 15 and June 18, 2009, indicating that the Pharmacy and Therapeutics Committee reported the changes regarding the Medication Ordering policy change. EMP6 revealed the pharmacy implemented the change to this Medication Ordering policy in June 2009.

Based on review of facility documents, medical records (MR) and staff interview (EMP), it was determined that the facility failed to ensure drug administration errors were reported to the attending physician for one of one applicable medical records (MR59).

Findings include:

Review on February 1, 2012, of the facility policy "Adverse Drug Events Reporting," last reviewed October 2011, revealed "Definitions: ... A medication error is any error in the process of prescribing, dispensing or administering of a drug while it is in the control of the health care professional, patient or consumer and whether there are adverse consequences or not. ... Medication Error Reporting: when a medication error occurs, the physician is to be notified. ... Only Documentation Required: 1. administration of the medication is documented on the appropriate patient's medical record form. A focus note is made with the medication given, physician notified and orders received. ..."

Review on February 1, 2012, of the facility policy "The Nursing Process," last reviewed April 2010, revealed "Policy: The Nursing Process is used by the professional nurse as a framework to assess patient needs and develop a plan of care to meet identified needs. ... Procedure: 1B. Systematically documents and communicates information concerning health status of the patient. ..."

Review on February 1, 2012, of MR59 revealed that on August 5, 2011, the physician ordered Demerol (a narcotic pain medication) 25 mg IM Q (every) 4 hours PRN (as needed) for pain. Continued review revealed the patient's medication administration record listed: Demerol 75 mg (milligram) IM (intramuscular). Nursing documentation on MR59's MAR revealed that on August 5, 2011, the patient received Demerol 75 mg IM. Further review of MR59 revealed no nursing documentation the attending physician was notified that MR59 received Demerol 75 mg and not the Demerol 25 mg as per the physician's order.

Interview with EMP2 and EMP11 at 2:45 PM on February 1, 2012, confirmed there was no documentation the nursing staff notified MR59's physician regarding the medication error.

Based on review of facility policy, observation, and interview of staff (EMP) it was determined that the facility failed to ensure trash, biohazardous waste, and soiled linen were properly stored in nursing unit 4B and Labor/Delivery room 3.

Findings include:

Review on January 31, 2012, of facility's "Housekeeping Department-Infection Control" policy, last reviewed August 2011, revealed "Policy: To maintain a clean environment to minimize the risk of environmental transmission of microorganisms to patient, staff and visitors. ... 6. Waste Disposal and Trash Containers ... B. Trash and infectious waste must not be allowed to accumulate on the floor of the soiled utility room. ..."

Review on January 31, 2012, of the facility's "Housekeeping Department - Infection Control" policy, last reviewed August 2011, revealed "Policy: To maintain a clean environment to minimize the risk of environmental transmission of microorganisms to patients, staff and visitors. ... F. Waste collection 1) Trash will be picked up at least twice per day (more often if required) and placed in the soiled utility rooms for subsequent pick up and transfer. 2) Infectious waste will be red bagged and placed in the soiled utility room for subsequent pick up ...6. Waste Disposal and Trash Containers ... B. Trash and infectious waste must not be allowed to accumulate on the floor of the soiled utility room. ..."

1) Tour on January 31, 2012, of nursing unit 4B, revealed one bag of trash stored on the floor of the Soiled Utility room.

Interview with EMP20 at 1:45 PM on January 31, 2012, confirmed the presence of one bag of trash on the floor of the Soiled Utility room.

2) Tour on January 31, 2012, of the obstetrical department revealed a full soiled linen container, a partially full red biohazardous waste bag and a partially full trash bag in the bathroom in Labor/Delivery room 3.

Interview with EMP7 and EMP8 on January 31, 2012, at approximately 9:30 AM revealed Labor/Delivery room 3 was considered ready for patient use. Further interview with EMP7 and EMP8 confirmed the soiled linen container, the red biohazardous waste bag and the trash bag were stored in the Labor/Delivery room, and that these waste bags were to be stored in the soiled utility room.

Based on review of facility documents, observation and staff interview (EMP), it was determined that the facility failed to provide proper signage for biohazard material in the obstetrical unit and the labor and delivery unit; failed to properly retain and store gross specimens of tissue, organs and bone in the laboratory's pathology storage area, the pathology department, the pathologist's office, the morgue cold storage area and in the morgue; failed to maintain the morgue in a sanitary manner; and failed to ensure clean environment was maintained in the Obstetrical Unit (OB), Nursery II, Labor and Delivery, nursing unit 3B, and nursing unit 3C (Tag A0749).

Findings include:

Review on January 31, 2012, of the facility's "Blood Borne Pathogens Exposure Control Plan," issued August 8, 2011, revealed "Policy: "Schuylkill Medical Center - South Jackson Street is committed to providing a safe and healthful work environment for our entire staff. In pursuit of this endeavor, the following exposure control plan (ECP) is provided to eliminate or minimize occupational exposure to bloodborne pathogens in accordance with OSHA standard 29 CFR 1910.030. "Occupational Exposure to Bloodborne Pathogens."... Program Administration The Infection Preventionist is responsible for the implementation of the ECP. ... Appropriate department heads/directors/managers will maintain and provide all necessary personal protective equipment (PPE), engineering controls (e.g., sharps containers), labels, and red bags as required by the standard. ...Methods of Implementation and Control ... Labels Warning labels shall be affixed to containers of regulated waste, refrigerators or freezers containing blood or other potentially infectious materials, and other containers used to store, transport or ship blood or other potentially infectious materials. ..."

1) Observation on January 31, 2012, of the obstetrical (OB) unit revealed a closet in located in the documentation area between Nursery I and Nursery II which contained bottles of formula and a refrigerator. Interview with EMP7 and EMP8 revealed this refrigerator was used to store a nursing mother's breast milk and that breast milk was considered a potentially infectious material. Further observation of this refrigerator revealed no biohazard labeling or signage indicating that the contents were potentially infectious materials.

Interview with EMP7 and EMP8 on January 31, 2012, at approximately 9:45 AM confirmed that breast milk was considered a potentially infectious material and that the refrigerator used to store the breast milk did not contain biohazard labeling or signage indicating the contents were potentially infectious materials.

2) Observation on January 31, 2012, of the Labor and delivery unit's clean utility room revealed a refrigerator. Interview with EMP7 and EMP8 revealed this refrigerator was used to store cord blood (umbilical cord blood that remained in the placenta and the attached umbilical cord after childbirth) and that cord blood was considered a potentially infectious material. Further observation of this refrigerator revealed no biohazard labeling or signage indicating that the contents were potentially infectious materials.

Interview with EMP7 and EMP8 on January 31, 2012, at approximately 9:55 AM confirmed the cord blood was considered a potentially infectious material and that the refrigerator used to store the cord blood did not contain biohazard labeling or signage indicating the contents were potentially infectious materials.
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Review on February 1, 2012, of the facility's "Retention Times For Records, Reports, Specimens," issued and approved April 28, 2011, revealed Policy: "The minimum retention times for various records, reports and specimens are listed below. The Laboratory conforms to regulations with the longest retention period. Description: Equipment records- daily, weekly, Monthly performance testing and function tests, PA. Bureau of Laboratories- 2 years, Joint Commission-2 years. Life of equipment- major repairs, parts replacement, and annual maintenance: Test requisitions- 2 years, Joint Commission 2 years. Records of Testing- (Instrument printouts and log sheets) Immunohematology 5 years. All others 2 years- PA Bureau of Laboratories. Joint Commission- Immunohematology- 5 years. All others 2 years. Test Reports (preliminary/final) Pathology-PA Bureau of Laboratories-10 years. Joint Commission - 10 years. Cytology- PA Bureau of Laboratories- 10 years. Immunohematology- PA Bureau of Laboratories- 5 years. Joint Commission 5 years. All Others- PA Bureau of Laboratories- 2 years. Joint Commission- 2 years. Proficiency Testing- Records of test, handling, preparation, testing, results of reporting, signed Attestation statement, scores and remedial action. PA Bureau of Laboratories- 2 years. Joint Commission 2 years. Quality Control. Immunohematology- PA Bureau of Laboratories- 5 years. Joint Commission- 5 years. All others- PA Bureau of Laboratories- 2 years. Joint Commission- 2 years. Discontinued Procedures- Immunohematology- PA Bureau of Laboratories- 5 years. Joint Commission 5 years. All Others- PA Bureau of Laboratories- 2 years. Joint Commission- 2 years. Blood/ Tissue Bank Records, * Specimens from blood donor units and recipients- PA Bureau Of Laboratories- Indefinite Retention. Joint Commission- Indefinite Retention (recipients- 10 days). Histology Specimens- Gross Specimens- PA Bureau of Laboratories- Until diagnosis is made. Joint Commission- 7 days after reporting. Slides- PA Bureau of Laboratories- 10 years. Joint Commission-10 years. Blocks- PA Bureau of Laboratories- 2 years. Joint Commission- 2 years. Cytology PA Bureau of Laboratories- Fine needle asp slides- 5 years. Joint Commission- 10 years. Slides- PA Bureau of Laboratories- 5 years. Joint Commission- 5 years. Clinical Laboratory Specimens. Serum/CSF/Body fluids (except urine)- Joint Commission - 7 days. Hematology/ coagulation specimens- Joint Commission- 48 hours. Urine- Joint Commission- 24 hours. Peripheral/Body Fluid Smears- Joint Commission- 7 days. Microbiology stained slides- Joint Commission- 7 days."

1) Tour on February 1, 2012, of the facility's laboratory revealed approximately 300 containers containing gross specimens, which included pieces of tissue, organ and bone. These specimens were randomly stored in the laboratory's pathology storage area, the pathology department, the pathologist's office, the morgue cold storage area and in the morgue. These containers of gross specimens were not sealed and had visible leakage noted on all sides of the containers making visualization of the date, identification of the specimen and description of the specimen unreadable. Further observation revealed these gross specimens were stored randomly on top of each other, two to three containers high and on shelves randomly placed throughout the laboratory's pathology storage area, the pathology department, the pathologist's office, the morgue cold storage area and in the morgue. These gross specimen containers were not stored in bio-hazard containers.

Interview with EMP22 on February 1, 2012, at approximately 12:30 PM confirmed there were approximate 300 containers containing gross specimens which included pieces of tissue, organ and bone that were randomly stored in the laboratory's pathology storage area, the pathology department, the pathologist's office, the morgue cold storage area. EMP22 confirmed these containers were not sealed and had visible leakage noted on all sides of these containers making visualization of the date, identification of the specimen and description of the specimen unreadable. EMP22 confirmed these gross specimens were stored indiscriminately (randomly) on top of each other throughout the laboratory's pathology storage area, the pathology department, the pathologist's office, the morgue cold storage area and in the morgue and that these gross specimen containers were not stored in any type of bio-hazard containers.

2) Observation on February 1, 2012, of the cold storage area of the morgue (the area reserved for the holding of deceased bodies) revealed approximately 30 containers of gross specimens which included pieces of tissue, organ and bone stored on two patient transport stretchers. The stretchers were covered with plastic covers, which resembled shrouds. This area had a distinct odor of decomposing tissue.

Interview with EMP22 on February 1, 2012, at approximately 12:45 PM confirmed the cold storage area of the morgue was reserved for the holding of deceased bodies and contained approximately 30 containers of gross specimens which included pieces of tissue, organ and bone. EMP22 confirmed the containers were stored on two patient transport stretchers and were covered with plastic covers. EMP22 confirmed the area had a distinct odor of decomposing tissue.

3) Observation on February 1, 2012, of the morgue revealed six cabinets with rust on the front doors from the top of the door to the bottom of the door. There were multiple areas of red brown colored fluid splatter on these cabinets. The floor drain under the autopsy table was blocked with unidentifiable material. A steel work table had autopsy instruments laid out on a cloth on top of the table.

Interview with EMP22 on February 1, 2012, at approximately 1:00 PM confirmed the morgue had six cabinets with rust on the front doors from the top of the door to the bottom of the door. EMP22 confirmed there were multiple areas of red brown colored fluid splatter on these cabinets. EMP22 confirmed the floor drain under the autopsy table was blocked with unidentifiable material.

Interview with EMP22 on February 1, 2012, at approximately 1:15 PM confirmed the gross specimens stored at the facility were from coroner's cases. EMP22 confirmed these specimens have been stored throughout the facility for over eight years. EMP22 confirmed they had exhausted proper storage space for the specimens. Further interview with EMP22 revealed the facility did not have a gross specimen log for tracking of these gross specimens. EMP22 noted the facility stopped performing autopsies on December 31, 2011.

Interview with EMP12 and EMP23 on February 1, 2012, at approximately 1:15 PM revealed that the Emergency Department staff was responsible for cleaning the morgue and the instruments used after autopsies were performed. They also confirmed the last time the morgue was cleaned was following an autopsy was before November 2011. EMP12 revealed the number of gross specimens stored in the morgue was a bio-hazard concern for several months and was discussed with the infection control manager. Further interview with EMP23 revealed the facility did not have a log for tracking the cleaning of the morgue.

The facility was unable to provide documentation regarding the cleaning of the morgue.

Interview with EMP12 and EMP15 on February 1, 2012, at approximately 1:30 PM confirmed the gross specimen storage and bio-hazard issues was a longtime facility infection control and safety concern.

Cross reference 482.42(a)(1) Infection Control Officer Responsibilities.

Based on observation, review of facility policies and staff interview (EMP), it was determined that the facility failed to ensure clean environment was maintained in the Obstetrical Unit (OB), Nursery II, Labor and Delivery, nursing unit 3B, and nursing unit 3C.

Findings include:

Review on January 31, 2012, of the facility's "Care of Equipment, Bed making, and Cleaning of Units" policy, last reviewed August 2011, revealed "Policy: The OB Staff will provide the patient with all equipment necessary and follow the below bed making and cleaning guidelines. Guidelines: ... 3. Cleaning the Unit: a. Bed linens and any other items left in the patient room ... will be removed by the OB staff. ... c. OB Staff will be responsible for cleaning all equipment including the baby beds, bassinettes [sic], isolettes ..."

Observation on January 31, 2012, at approximately 9:00 AM revealed a radiant warmer in the OB unit's nursery II.

Interview with EMP7 and EMP8 on January 31, 2012, at approximately 9:00 AM revealed the Nursery II area, as well as the contents of the room, was considered clean.

Interview with EMP9 on January 31, 2012, at approximately 9:00 AM revealed EMP9 returned the radiant warmer from the operating room following the delivery of a baby; that this radiant warmer was considered dirty; and that the radiant warmer was placed in the clean Nursery II for cleaning.

Interview with EMP7, EMP8 and EMP9 January 31, 2012, at approximately 9:05 AM confirmed the dirty radiant warmer was placed in a clean nursery area.
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Review on January 31, 2012, of the facility's "Housekeeping Department - Infection Control" policy, last reviewed August 2011, revealed "Policy: To maintain a clean environment to minimize the risk of environmental transmission of microorganisms to patients, staff and visitors. ..."

1) Observation on January 31, 2012, of the nursing unit 3B revealed food debris inside the microwave used to prepare patient food.

Interview with EMP20 at 9:45 AM on January 31, 2012, confirmed the presence of food debris inside the microwave used to prepare patient food.

2) Observation on January 31, 2012, of the OB patient food pantry revealed food debris inside the microwave used to prepare patient food. Further observation revealed a toaster used to prepare patent food with food debris and dust.

Interview with EMP7 and EMP8 on January 31, 2012, at approximately 10:00 AM confirmed the presence of food debris on the microwave and toaster used to prepare patient food.
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Review on January 31, 2012, of the facility's "Soiled Linen Operations" policy, last reviewed August 2011, revealed "Policy: 1. Infection Control guidelines shall be adhered to in soiled linen practices to be in compliance with all regulatory agency requirements that govern: ... B. Soiled linen collection, transport and storage. ... 2. Soiled linen handling: ... D. The soiled linen bags will be placed directly into a soiled linen cart ..."

1) Observation on January 31, 2012, of the obstetrical department revealed a full soiled linen container, a partially full red biohazardous waste bag and a partially full trash bag in the bathroom in Labor/Delivery room 3.

Interview with EMP7 and EMP8 on January 31, 2012, at approximately 9:30 AM revealed Labor/Delivery room 3 was considered ready for patient use. Further interview with EMP7 and EMP8 confirmed the full soiled linen container, partially full red biohazardous waste bag, and partially full trash bag were not to be stored in the Labor/Delivery room's bathroom and were to be stored in the soiled utility room.

2) Observation on January 31, 2012, of the obstetrical department revealed two full soiled linen bags stored on the floor of the soiled utility room.

Interview with EMP7 and EMP8 on January 31, 2012, at approximately 9:40 AM confirmed there were two full soiled linen bags stored on the floor of the soiled utility room.

3) Observation on January 31, 2012, of the nursing unit 3C revealed two green plastic bags of soiled linen stored on the floor of the soiled utility room.

Interview with EMP20 at 11:30 AM on January 31, 2012 confirmed the presence of two green plastic bags of soiled linen stored on the floor of the soiled utility room.

Based on review of facility documents, observation and staff interview (EMP), it was determined that the facility failed to provide proper signage for biohazard material in the obstetrical unit and the labor and delivery unit; failed to properly retain and store gross specimens of tissue, organs and bone in the laboratory's pathology storage area, the pathology department, the pathologist's office, the morgue cold storage area and in the morgue; failed to maintain the morgue in a sanitary manner; and failed to ensure clean environment was maintained in the Obstetrical Unit (OB), Nursery II, Labor and Delivery, nursing unit 3B, and nursing unit 3C (Tag A0749).

Findings include:

Review on January 31, 2012, of the facility's "Blood Borne Pathogens Exposure Control Plan," issued August 8, 2011, revealed "Policy: "Schuylkill Medical Center - South Jackson Street is committed to providing a safe and healthful work environment for our entire staff. In pursuit of this endeavor, the following exposure control plan (ECP) is provided to eliminate or minimize occupational exposure to bloodborne pathogens in accordance with OSHA standard 29 CFR 1910.030. "Occupational Exposure to Bloodborne Pathogens."... Program Administration The Infection Preventionist is responsible for the implementation of the ECP. ... Appropriate department heads/directors/managers will maintain and provide all necessary personal protective equipment (PPE), engineering controls (e.g., sharps containers), labels, and red bags as required by the standard. ...Methods of Implementation and Control ... Labels Warning labels shall be affixed to containers of regulated waste, refrigerators or freezers containing blood or other potentially infectious materials, and other containers used to store, transport or ship blood or other potentially infectious materials. ..."

1) Observation on January 31, 2012, of the obstetrical (OB) unit revealed a closet in located in the documentation area between Nursery I and Nursery II which contained bottles of formula and a refrigerator. Interview with EMP7 and EMP8 revealed this refrigerator was used to store a nursing mother's breast milk and that breast milk was considered a potentially infectious material. Further observation of this refrigerator revealed no biohazard labeling or signage indicating that the contents were potentially infectious materials.

Interview with EMP7 and EMP8 on January 31, 2012, at approximately 9:45 AM confirmed that breast milk was considered a potentially infectious material and that the refrigerator used to store the breast milk did not contain biohazard labeling or signage indicating the contents were potentially infectious materials.

2) Observation on January 31, 2012, of the Labor and delivery unit's clean utility room revealed a refrigerator. Interview with EMP7 and EMP8 revealed this refrigerator was used to store cord blood (umbilical cord blood that remained in the placenta and the attached umbilical cord after childbirth) and that cord blood was considered a potentially infectious material. Further observation of this refrigerator revealed no biohazard labeling or signage indicating that the contents were potentially infectious materials.

Interview with EMP7 and EMP8 on January 31, 2012, at approximately 9:55 AM confirmed the cord blood was considered a potentially infectious material and that the refrigerator used to store the cord blood did not contain biohazard labeling or signage indicating the contents were potentially infectious materials.
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Review on February 1, 2012, of the facility's "Retention Times For Records, Reports, Specimens," issued and approved April 28, 2011, revealed Policy: "The minimum retention times for various records, reports and specimens are listed below. The Laboratory conforms to regulations with the longest retention period. Description: Equipment records- daily, weekly, Monthly performance testing and function tests, PA. Bureau of Laboratories- 2 years, Joint Commission-2 years. Life of equipment- major repairs, parts replacement, and annual maintenance: Test requisitions- 2 years, Joint Commission 2 years. Records of Testing- (Instrument printouts and log sheets) Immunohematology 5 years. All others 2 years- PA Bureau of Laboratories. Joint Commission- Immunohematology- 5 years. All others 2 years. Test Reports (preliminary/final) Pathology-PA Bureau of Laboratories-10 years. Joint Commission - 10 years. Cytology- PA Bureau of Laboratories- 10 years. Immunohematology- PA Bureau of Laboratories- 5 years. Joint Commission 5 years. All Others- PA Bureau of Laboratories- 2 years. Joint Commission- 2 years. Proficiency Testing- Records of test, handling, preparation, testing, results of reporting, signed Attestation statement, scores and remedial action. PA Bureau of Laboratories- 2 years. Joint Commission 2 years. Quality Control. Immunohematology- PA Bureau of Laboratories- 5 years. Joint Commission- 5 years. All others- PA Bureau of Laboratories- 2 years. Joint Commission- 2 years. Discontinued Procedures- Immunohematology- PA Bureau of Laboratories- 5 years. Joint Commission 5 years. All Others- PA Bureau of Laboratories- 2 years. Joint Commission- 2 years. Blood/ Tissue Bank Records, * Specimens from blood donor units and recipients- PA Bureau Of Laboratories- Indefinite Retention. Joint Commission- Indefinite Retention (recipients- 10 days). Histology Specimens- Gross Specimens- PA Bureau of Laboratories- Until diagnosis is made. Joint Commission- 7 days after reporting. Slides- PA Bureau of Laboratories- 10 years. Joint Commission-10 years. Blocks- PA Bureau of Laboratories- 2 years. Joint Commission- 2 years. Cytology PA Bureau of Laboratories- Fine needle asp slides- 5 years. Joint Commission- 10 years. Slides- PA Bureau of Laboratories- 5 years. Joint Commission- 5 years. Clinical Laboratory Specimens. Serum/CSF/Body fluids (except urine)- Joint Commission - 7 days. Hematology/ coagulation specimens- Joint Commission- 48 hours. Urine- Joint Commission- 24 hours. Peripheral/Body Fluid Smears- Joint Commission- 7 days. Microbiology stained slides- Joint Commission- 7 days."

1) Tour on February 1, 2012, of the facility's laboratory revealed approximately 300 containers containing gross specimens, which included pieces of tissue, organ and bone. These specimens were randomly stored in the laboratory's pathology storage area, the pathology department, the pathologist's office, the morgue cold storage area and in the morgue. These containers of gross specimens were not sealed and had visible leakage noted on all sides of the containers making visualization of the date, identification of the specimen and description of the specimen unreadable. Further observation revealed these gross specimens were stored randomly on top of each other, two to three containers high and on shelves randomly placed throughout the laboratory's pathology storage area, the pathology department, the pathologist's office, the morgue cold storage area and in the morgue. These gross specimen containers were not stored in bio-hazard containers.

Interview with EMP22 on February 1, 2012, at approximately 12:30 PM confirmed there were approximate 300 containers containing gross specimens which included pieces of tissue, organ and bone that were randomly stored in the laboratory's pathology storage area, the pathology department, the pathologist's office, the morgue cold storage area. EMP22 confirmed these containers were not sealed and had visible leakage noted on all sides of these containers making visualization of the date, identification of the specimen and description of the specimen unreadable. EMP22 confirmed these gross specimens were stored indiscriminately (randomly) on top of each other throughout the laboratory's pathology storage area, the pathology department, the pathologist's office, the morgue cold storage area and in the morgue and that these gross specimen containers were not stored in any type of bio-hazard containers.

2) Observation on February 1, 2012, of the cold storage area of the morgue (the area reserved for the holding of deceased bodies) re