Summary:
Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to test the microbiology (bacteriology) and hematology (mycology, parasitology, urine microscopic analysis and semen analysis) proficiency testing samples the same number of times that it routinely tests patient samples for five (2nd and 3rd events in 2016 and 1st-3rd events in 2017) of five events reviewed. Findings include: 1. On April 2, 2018 at 11:56 a.m., record review of the American Proficiency Institute (API) revealed for five of five events in 2016 and 2017 the laboratory had multiple testing reports for each analyte in the microbiology and hematology sections as follows: a. hematology 2nd event 2016 - all testing completed by ten personnel b. microbiology 2nd event 2016 - all testing completed by five personnel c. microbiology 3rd event 2016 - all testing completed by seven personnel d. hematology 1st event 2017 - all testing completed by ten personnel e. microbiology 1st event 2017 - all testing completed by seven personnel f. hematology 2nd event 2017 - all testing completed by ten personnel g. microbiology 2nd event 2017 - all testing completed by nine personnel h. hematology 3rd event 2017 - all testing completed by eleven personnel i. microbiology 3rd event 2017 - all testing completed by ten personnel 2. During the interview on April 2, 2018 at 11:56 a. m., the office manager confirmed the proficiency testing samples were not tested like patient samples. ***Repeat Deficiency from December 13, 2011 survey*** D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to maintain the original American Proficiency Institute (API) proficiency testing program report forms, worksheet log, and/or the signed attestation statement sheet for five (2nd and 3rd events in 2016 and 1st-3rd events in 2017) of five events reviewed. Findings include: 1. On April 2, 2018 at 11:56 a.m., record review of the final graded API proficiency testing reports revealed the laboratory failed to maintain the original proficiency testing program report forms, worksheet logs, and the signed attestation statement sheets for five of five events in 2016 and 2017 as follows: a. microbiology original paperwork - 2nd event in 2016 and 1st and 2nd events in 2017 b. hematology original paperwork - 2nd and 3rd events in 2016 and 1st event in 2017 c. microbiology worksheet logs - 2nd event 2016 d. hematology signed attestation statement sheets - 3rd event in 2016 and 2017 2. During the interview on April 2, 2018 at 11:56 a.m., the office manager confirmed the laboratory failed to maintain all the proficiency testing program report form, microbiology worksheet logs, and the signed attestation statement sheets. . 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 record review and interview, the laboratory failed to ensure written competency policies were established, contained the requirements from subpart M, and implemented for 15 (#1 - #15) of 15 testing personnel performing the bacteriology, mycology, parasitology, urine microscopic analysis, and the hematology semen analysis in 2016 and 2017. Findings include: 1. On April 2, 2018 at 10:46 a.m., record review revealed the laboratory did not establish a written competency policy that included the six requirements from subpart M for the bacteriology, mycology, parasitology, urine microscopic analysis, and the hematology semen analysis that included the following: a. Direct observations of routine patient test performance, patient preparation, specimen handling, processing, and testing. b. Monitoring the recording and reporting of patient test results. c. Review of test results, worksheets, quality control records, proficiency testing results, and preventive maintenance. d. Direct observation of performance of instrument maintenance and function checks. e. Assessment of test performance through testing previously analyzed samples. f. Assessment of problem solving skills. 2. On April 2, 2018 at 10:46 a.m., record review revealed the laboratory did not have any documentation to show that for 15 of -- 2 of 8 -- 15 testing personnel the competency assessments were performed and documented for the bacteriology, mycology, parasitology, urine microscopic analysis, and the hematology semen analysis testing in 2016 and 2017. 3. On April 2, 2018 at 10:46 a. m. when queried, the office manager was not able to provide the surveyor with a competency policy that contained the six minimal requirements and the documentation of those requirements for 15 of 15 testing personnel in 2016 and 2017. 4. During the interview on April 2, 2018 at 10:46 a.m., the office personnel confirmed the laboratory did not establish a competency policy that contained the requirements from Subpart M and did not implement the policy in 2016 and 2017. ***Repeat Deficiency from December 13, 2011 Survey*** D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to establish and follow written procedures for the microbiology and hematology testing. Refer to D5401. 2. The laboratory failed to follow the manufacturer's operator's manual to monitor and record room temperatures and humidity. Refer to D5411. 3. The laboratory failed to monitor and document the incubator temperature. Refer to D5413. 4. The laboratory failed to label the potassium hydroxide (KOH) reagent with the preparation and expiration date . Refer to D5415. 5. The laboratory failed to perform and document the two times per year maintenance on the stat spin centrifuges. Refer to D5429. 6. The laboratory failed to check each batch, lot number, and shipment of Bacitracin discs for positive and negative reactivity . Refer to D5471. 7. The laboratory failed to perform and document media checks with each new batch, lot, or shipment for sterility, the ability to support growth, and selectivity/inhibition of growth. Refer to D5477. 8. The laboratory failed to document