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 record review and interview, the laboratory director and the testing personnel failed to attest to the integration of the routine chemistry and toxicology proficiency testing samples into the patient workload for four (3rd event 2016, 1st and 2nd events 2017, and 1st event 2018) of four events reviewed. Findings include: 1. On October 15, 2018 at 10:00 AM, record review of the American Proficiency Institute (API) routine chemistry and toxicology proficiency testing documents revealed the laboratory director and the testing personnel did not sign the attestation statement sheets for the following events: a. 3rd event in 2016 b. 1st and 2nd events in 2017 c. 1st event in 2018 2. During the interview on October 15, 2018 at 10:00 AM, the office liaison confirmed the attestation statement sheets were not signed. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, 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 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 -- 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 retain the original American Proficiency Institute (API) proficiency testing program report forms and the Thermo Scientific Indiko Plus instrument printouts for four (3rd event 2016, 1st and 2nd events 2017, and 1st event 2018) of four testing events reviewed. Findings include: 1. On October 15, 2018 at 10:00 AM, record review of the final API proficiency testing reports revealed the laboratory failed to retain the original proficiency testing program report forms and the chemistry instrument printouts as follows: a. 3rd event 2016 b. 1st and 2nd events 2017 c. 1st event 2018 2. During the interview on October 15, 2018 at 10:00 AM, the office liaison confirmed the laboratory did not retain all the documentation for the proficiency testing events. . 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: . Based on record review and interview, the laboratory failed to retain 1) the temperature logs for two (December 2016 and April 2018) of 24 months and 2) the monthly quality assessment checklists for two (November 2016 and April 2018) of 24 months reviewed for two years. Findings include: 1. On October 15, 2018 at 12:40 PM, record review of the monthly temperature logs and the quality assessment checklists revealed the laboratory did not retain the documentation for two years as follows: a. temperature logs - no documentation for December 2016 and April 2018 b. quality assessment checklists - no documentation for November 2016 and April 2018 2. During the interview on October 15, 2018 at approximately 3:15 PM, the office manager, liaison, and testing personnel #2 as listed on the CMS-209 confirmed the temperature logs and the quality assessment checklists were not retained for two years. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interview, the laboratory failed to meet the requirements for the specialty in Toxicology as specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to implement competency assessments. Refer to D5209. 2. The laboratory failed to verify the accuracy of the urine toxicology specific gravity, pH, and creatinine testing. Refer to D5217. 3. The laboratory failed to have an electronic request for patient testing. Refer -- 2 of 7 -- to D5301. 4. The laboratory failed to monitor and document temperatures. Refer to D5413. 5. The laboratory failed to perform and document refrigerator, room temperature/humidity thermometer validations. Refer to D5429. 6. The laboratory failed to perform the daily quality control for the routine chemistry and toxicology testing. Refer to D5445. 7. The laboratory failed to document