Summary:
Summary Statement of Deficiencies D0000 This is the initial survey of the laboratory conducted on 1/31/2018 through 2/1/2018. At the time of the initial survey the laboratory was not in compliance with the following conditions with immediate jeopardy: 493.801 Enrollment and Testing of Proficiency Samples 493.1230 General Laboratory Systems 493.1240 Preanalytic Systems (Immediate Jeopardy) 493.1250 Analytic Systems (Immediate Jeopardy) 493.1403 Laboratory Director Moderate Complexity (Immediate Jeopardy) 493.1409 Technical Consultant Moderate Complexity (Immediate Jeopardy) 493.1441 Laboratory Director High Complexity (Immediate Jeopardy) 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: Through observation, lack of documentation, and interview it was determined that the laboratory failed to monitor room temperature in two of four rooms ( identified as room numbers 1,2,3, and 4 on Vitas laboratory evacuation plan diagram) in which supplies with temperature requirements were stored. Not following manufacturer's storage instructions for test supplies and reagents has the potential of affecting all patients tested. Findings follows: A. During a tour of the laboratory on 1/31/18 at approximately 03:15 p.m., eleven ea. Clarity Drugs of Abuse screening kits lot # D1709160 with an expiration date of 2018-08 and a temperature requirement of 2 degrees C to 30 degrees C. were observed in a closed storage room identified as number 3 on a Vitas evacuation plan diagram. B. Upon request, the laboratory was unable to provide temperature records for the storage room numbers 3 as identified Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 19 -- above. C. In an interview on 1/31/18 at approximately 03:30 p.m., the technical consultant identified as number 1 on the CMS 209 form confirmed that the room temperature had not been monitored on the storage room identified above D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Through a review of verification studies for the Sysmex Hematology analyzer, patient testing logs, lack of documentation, as well as interviews with staff, it was determined the Laboratory failed to enroll in proficiency testing for the Specialty of Hematology and Virology as evidenced by: A. A review of the verification studies for Sysmex Hematology analyzer revealed the Laboratory started patient testing for Complete Blood Counts (CBC) on September 18, 2017. B. A review of patient testing logs revealed the laboratory analyze the following viruses on the Verigene Respiratory PCR instrument: Adenovirus, Human Metapneumovirus, Influenza A- Subtype H1, Influenza A-Subtype H3, Influenza B (Parainfluenza type 1-4) Respiratory Syncytial Virus A&B and Rhinovirus. C. A review of patient testing logs for Virology revealed the Laboratory started patient testing on December 13, 2017. D. The surveyor requested Proficiency testing documentation for Hematology and Virology none was provided. There was no documentation that the laboratory had enrolled in proficiency testing program. E. In an interview on 01/31/2018 at 1:00 p.m., the technical consultant ( as listed on CMS form 209) confirmed the Laboratory did not enrolled in proficiency testing until January 15, 2018. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Through a review of Quality Control data, lack of documentation, as well as interview with laboratory staff, it was determined the laboratory failed to retain quality control records for at least two years. As evidenced by: A. A review of Hematology Quality Control (QC) daily printouts for the month of September 2017 revealed the Laboratory failed to retain the Sysmex e-check assay logs which contained the QC ranges for Lot # 72130804-Level I, Lot #72130805-Level II and Lot #72130806-Level III put in use on September 14, 2017. B. A review of Hematology QC daily printouts for the month of October 2017, revealed the Laboratory started a new lot of QC on 10/23/2017. The surveyor requested the Sysmex e-check assay logs -- 2 of 19 -- for Lot #72690804-Level, Lot #72690805-Level II and Lot #72690806, none was provided. C. In an interview at 09:30 am on 02/01/2018, Laboratory employee #8 (as listed on form CMS-209) stated that the Sysmex e-check assay QC logs for September and October 2017 were not available. 35659 Through review of LC/MS quality control policy , quality control reports, lack of documentation, and interview it was determined that the laboratory failed to document