Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing documentation and staff interview, the laboratory director or designee failed to sign the attestation statement for proficiency testing modules in 2018. Findings include: a) Review of College of American Pathologists (CAP) proficiency testing records revealed the laboratory director or designee did not sign the attestation statement for the following modules in 2018: a. 1st event, 2018FH9 (FH9) Hematology, (1 of 2 events) b) In an interview conducted on August 20, 2018 at 10:00 AM, the technical consultant confirmed the attestation statements were not signed for the modules mentioned above by the laboratory director or designee. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the Point of Care (POC) Quality Program and staff interview, the technical; consultant failed to follow the laboratory's Quality Assurance (QA) plan for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- documentation of training and review of temperature logs for 2 of 2 years ( 2016- 2018). Findings include: 1) Review of the POC Quality Program revealed the technical consultant did not follow the laboratories policy for documentation of initial training for each employee. The POC Quality Program states on page 4 & 5 under the Education, Training and Competency section: b. "For non-waived testing all TPs must receive initial training, semi-annual competency assessment in the first year" d. "Documentation of the initial training/ competency assessment, semiannual competency and annual competency shall be maintained in the employee's education file on the testing unit or in some cases on training logs." a) In an interview conducted on August 20, 2018 at 10:30 AM, the technical consultant confirmed there was no initial training documentation for years 2016-2018. 2) Review of the POC Quality Program revealed the technical consultant did not follow the laboratories policy for monitoring the temperatures in the laboratory for the following: a) The POC Quality Program states on page 9 under the Temperature monitoring section "Temperature logs will be reviewed monthly by the POC Specialist or designee." The Technical Consultant failed to monitor for the following dates: i. August 2016 - December 2016 ii. January 2017 to December 2107 iii. January 2018 to August 2018 b) In an interview conducted on August 20, 2018 at 10:30 AM, the technical consultant confirmed there was no review of temperature log sheets from August 28, 2016 to August 17, 2018 3) Review of the POC Quality Program revealed the technical consultant did not follow the laboratories policy for documenting