Summary:
Summary Statement of Deficiencies D0000 A complaint investigation survey was conducted at the facility May 24, 2018. Based on the survey findings, an Immediate Jeopardy situation was identified and the laboratory was notified June 14, 2018 at approximately 4:55 p.m. The laboratory failed to identify and correct problems in the general laboratory systems. The laboratory failed to establish and follow policies and procedures for evaluating testing personnel competency and failed to enroll in proficiency testing or establish a system to verify the accuracy of its fern and wet prep/KOH (potassium hydroxide) tests at least twice a year. The laboratory director failed to provide overall management and direction for the laboratory. The laboratory director failed to ensure written procedures were established and followed for the performance of laboratory tests. The laboratory director failed to ensure laboratory test reports included all required information. The laboratory director failed to ensure job descriptions indicated the laboratory duties and responsibilities each testing personnel was authorized to perform and failed to ensure testing personnel were trained and the training was documented prior to testing patient specimens. Based on the severity of the deficiencies, the Immediate Jeopardy was not abated and the laboratory was placed on a 23 day revocation track. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturers' instructions, observation, and staff interview 5/24 /18 the laboratory failed to follow manufacturers' instructions for storage of reagents and supplies to ensure accurate and reliable test performance. Findings: During a tour of the laboratory at approximately 2:20 p.m., surveyors observed the following Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- supplies stored in the laboratory at room temperature: McKesson Consult Diagnostics 10SG Urine Reagent Strips, Consult hCG Diagnostics Urine Test cartridges, and Alere HemoPoint H2 Microcuvettes. Review of manufacturers' instructions revealed: 1. The McKesson Consult Diagnostics 10SG Urine Reagent Strips product insert states, "...STORAGE AND STABILITY...Store as package in the closed canister or the sealed pouch either at room temperature or refrigerated (2-30 Degrees C or 36-86 Degrees F)....DO NOT FREEZE...". 2. The Consult HCG Diagnostics Urine Test product insert states, "...STORAGE AND STABILITY...Store as packaged in the sealed pouch at 36-86 Degrees F / 2-30 Degrees C...DO NOT FREEZE...". 3. The Alere HemoPoint H2 User Manual states, "... 4.1 Taking a Sample ... Pay attention to the following notes, to preserve the integrity of the Alere HemoPoint H2 Microcuvette: Store the cuvettes only in the original container and at room temperature (59-86 degrees F / 15-30 degrees C). ..." During interview at 5:00 p.m., the Regional Director of Clinical Operations stated that they were not aware that monitoring the storage conditions (room temperature) was required by manufacturer. She verified that the laboratory had not monitored and documented room temperature in the laboratory on a daily basis. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the absence of records, the deficiencies cited at D5209 and D5217, review of compliance checklists, and interview with staff 5/24/18, the laboratory failed to establish and follow policies and procedures for a comprehensive quality assessment program designed to identify and correct problems in the general laboratory systems and prevent their recurrence. The laboratory did not have have a written quality assessment plan available for review at the time of the survey. The laboratory failed to identify and correct problems in the general laboratory systems identified during the survey: 1. The laboratory failed to establish and follow policies and procedures for evaluating testing personnel competency (see D5209). 2. The laboratory failed to enroll in proficiency testing or establish a system to verify the accuracy of its fern and wet prep/KOH (potassium hydroxide) tests at least twice a year (see D5217). During interview at approximately 6:20 p.m., the Senior Vice President of Clinical Programs stated that they have clinical compliance checklists that they complete on a routine basis, but they don't include specific laboratory items such as personnel competency and verification of accuracy for fern and wet prep/KOH tests. Review of the "Clinical Compliance Checklist (Monthly)" and the "CABC Compliance Checklist (Biannual)" revealed: 1. The "Clinical Compliance Checklist (Monthly)" stated on page 2-3 "... Clinical Equipment (Visually inspect; check batteries or electrical cords, if applicable; determine if additional maintenance required based on manufacturer specifications. A check indicates all such items are in working order. Leave unchecked and write a note if needing maintenance/repair or this item is not present in your facility.)" The -- 2 of 7 -- equipment list included the Microscope, Glucometer, and Hemapoint. 2. "CLIA license" was the only laboratory item on the "CABC Compliance Checklist (Biannual)". D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel records and staff interview 5/24/18, the laboratory failed to establish and follow written policies and procedures for assessing the competency of testing personnel. Review of personnel records for 11 of 11 testing personnel who perform fern and wet prep/KOH (potassium hydroxide) tests revealed there were no competency evaluation records available for review. During the survey at approximately 2:50 p.m., the Regional Director of Clinical Operations provided surveyors with a "Proficiency Testing for CLIA" document (last modified 4/5/18) which stated "The ability to perform microscopy should be assessed following hiring and periodically thereafter. Retraining and reassessment of performance needs to be done when problems are identified with employee performance. A CLIA competency assessment form (below) will be completed on hire and thereafter on an annual basis. ..." The "CLIA Competency Assessment" form stapled to the "Proficiency Testing for CLIA" document included employee instructions to watch a training video, review the procedure, and perform the procedure while being observed. The form also included instructions for the "observer" to directly observe the employee's performance of each step of the procedure and test the employee's problem solving skills with a question or observe the employee resolving a problem. The form included assessment of specimen handling, test performance, quality control, data management, and problem solving, with satisfactory or unsatisfactory performance. Spaces for comments and