Summary:
Summary Statement of Deficiencies 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 lack of Cobas 6000 chemistry calibration records, the Chemistry Calibration Policy and confirmed by laboratory personnel identifier #10 (refer to Laboratory Personnel Report) at approximately 2:40 pm on 04/03/2019, the laboratory failed to retain a copy of calibration records for the electrolytes: sodium, potassium, and chloride for 21 out of 24 months from 4/1/2017 - 4/1/2019. The findings include: 1. The Chemistry Calibration Policy (effective 4/5/2017) stated, "All calibration reports will be placed in a drawer and kept for 2 months. The calibration data is stored on our Cobas 6000 and is retrievable from the analyzer." 2. The laboratory had calibration records for the electrolytes: sodium, potassium and chloride from 2/1/2019 - 4/3/2019. 3. Laboratory Personnel identifier #10 confirmed that calibration records for sodium, potassium and chloride prior to 2/1/2019 could not be retrieved from the Cobas 6000 chemistry analyzer. 4. At the time of the survey, the laboratory did not have any additional calibration records for the electrolytes: sodium, potassium and chloride prior to 2/1/2019. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This CONDITION is not met as evidenced by: Based on review of Sysmex CS2500 coagulation reagent verification records from December 2018, observations of the coagulation analyzer and confirmed by laboratory personnel identifier #20 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 04/03/2019, the laboratory failed to meet the hematology (coagulation) requirements for test system/equipment/reagent verification as specified in the standard D5411. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of Sysmex CS2500 coagulation reagent verification records from December 2018, observations of the coagulation analyzer and confirmed by laboratory personnel identifier #20 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 04/03/2019, the laboratory failed to program the correct normal patient mean for lot number 549724, expiration date 11/16/20 of Prothrombin Time (PT) reagent into the Sysmex CS2500 coagulation analyzer. The findings include: 1. The laboratory must establish a normal patient mean with each new lot number of PT reagent. 2. For lot number 549724, expiration date 11/16/20 of PT reagent the laboratory established a normal patient mean of 10.3 seconds. 3. At the time of the survey, the laboratory had programmed into the Sysmex CS2500 coagulation analyzer the normal patient mean as 10.5 seconds. 4. Laboratory personnel identifier #20, confirmed the laboratory did not have the correct established normal patient mean programmed into the Sysmex CS2500 coagulation analyzer. D5641 CYTOLOGY CFR(s): 493.1274(d)(2)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(2)(ii) For the purposes of establishing workload limits for individuals examining slides in less than an 8-hour workday (includes full-time employees with duties other than slide examination and part-time employees), a period of 8 hours is used to prorate the number of slides that may be examined. The formula-- Number of hours examining slides X 100 / 8 is used to determine maximum slide volume to be examined; This STANDARD is not met as evidenced by: Based on review of the laboratory's workload limit procedure and confirmed by laboratory personnel identifier #13 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 04/03/2019, the laboratory failed to establish and follow a written workload limits procedure that ensures the workload limits are established and the number of slides examined prorated based on an 8-hour workday for one out of one part-time cytotechnologist (identifier #30). The findings include: 1. Personnel identifier #13 stated that the laboratory hired personnel identifier #30 in December -- 2 of 5 -- 2018 as a part-time cytotechnologist and that personnel identifier #30 also worked at another location as a full-time employee. 2. Review of the workload limits procedure indicated that the laboratory based workload limit assessments for personnel identifier #30 on a maximum of 100 cytology slides in a 24-hour period, screened in an 8-hour period. 3. Personnel identifier #13 confirmed that the laboratory did not prorate the number of slides that may be examined by personnel identifier #30 at Weland Clinical Labs. D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, laboratory records, interview with the Laboratory Operations Manager, and confirmed by laboratory personnel identifier #13 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 04/03/2019, the laboratory failed to establish and follow written policies and procedures to maintain records of the total number of gynecological and non-gynecological cytology slides examined by six out of 10 testing personnel (personnel identifiers #1 and #25- #29) who examine slides and the number of hours spent examining slides during each 24-hour period in 2018 and to the date of the survey in 2019. The findings include: 1. The Laboratory Operations Manager stated that personnel identifiers #1 and #25- #29 each examine gynecological and non-gynecological cytology slides for the laboratory. 2. At the time of the survey, personnel identifier #13 confirmed that the laboratory did not have a written policy or procedure for maintaining records of gynecological and non-gynecological slides examined and the time spent examining them for each individual during each 24-hour period. 3. At the time of the survey, personnel identifier #13 confirmed that the laboratory did not have records of gynecological and non-gynecological slides examined and the time spent examining them available for personnel identifiers #1 and #25-#29 from 2018 and up to the date of the survey in 2019. D5783