Infusion Clinic Laboratory

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/15/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with technical consultant #2 at the conclusion of the survey. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with technical consultant #2, the laboratory failed to ensure BD Macro-vue RPR card antigen suspension had not exceeded their refrigerated temperature expiration date for one of one dispensing bottles observed. Findings include: (1) On 04/15/2024 at 1:30 pm, technical consultant #2 stated syphilis testing (Rapid Plasma Reagin or RPR) was performed using the BD Macro-vue RPR Card test kit; (2) Observation of the laboratory on 04/15 /2024 at 1:30 pm identified one antigen dispensing bottle stored refrigerated, without documentation of when the antigen was transferred to the dispensing bottle; (3) Review of the manufacturer's storage requirements showed the following: (a) The antigen suspension is stable until the expiration date when unopened; (b) Once the antigen is put in the plastic dispensing bottle, it is stable for three months refrigerated. (4) Interview with technical consultant #2 on 04/15/2024 at 1:42 pm confirmed the antigen had been transferred into the plastic dispensing bottle without a method to monitor if they exceeded the manufacturer's modified expiration date. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/20/2022. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with technical consultant #2 and technical consultant #3 at the conclusion of the survey. 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 a review of records, written policy, and interview with technical consultant #2, the laboratory failed to have a written technical consultant competency policy based on the position responsibilities as listed in Subpart M. Findings include: (1) On 04/20/2022, a review of the competency assessment policy revealed there was no guidance, including the frequency, for assessing the competency of the technical consultants; (2) A review of personnel records for competency assessments performed from 2020 through the current date in 2022 revealed competencies had not been performed in 2021 for two of three technical consultants (technical consultant #1 and technical consultant #2), based on job responsiblitilies; (3) The findings were reviewed with technical consultant #2 who stated on 04/20/2022 at 11:49 am, a policy had not been written and competencies had not been performed for the two technical consultants in 2021 as shown above. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2, the laboratory failed to ensure the reportable ranges had been utilized for two of six analytes reviewed. Findings include: (1) On 04/20/2022 at 10:00 am, technical consultant #2 stated the following: (a) The laboratory began performing AST (Aspartate Aminotransferase), Calcium, Glucose, LD (Lactate Dehydrogenase), CA (Cancer Antigen) 15-3, and Ferritin testing using the Cobas 6000 analyzer on 06/01 /2021; (2) A review of the performance specification records, reportable ranges programmed in the analyzer, and the manufacturer's package inserts for the analytes revealed the laboratory was not using the reportable ranges that had been demonstrated for two of six analytes reviewed as follows: (a) CA 15-3 - The laboratory had demonstrated a reportable range of 3.047-247.567 U/ml and was using the manufacturer's reportable range of 1.0-300 U/ml; (b) Ferritin - The laboratory had demonstrated a reportable range of 0.9960-1762.0 ng/ml and was using the manufacturer's reportable range of 0.5-2000 ng/ml. (3) On 04/20/2022 at 01:10 pm, the findings were reviewed with technical consultant #2, who stated the laboratory was not able to enter the demonstrated reportable ranges for CA 15-3 and Ferritin into the analyzers and did not have access to update the reportable ranges in the LIS (Laboratory Information System), therefore the system defaulted to using the manufacturer's reportable ranges. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/23/2020. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with technical consultant #1 and technical consultant #2 at the conclusion of the survey. 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 a review of records and interview with technical consultant #3, the laboratory failed to retain centrifuge function check records for at least 2 years. Findings include: (1) At the beginning of the survey, technical consultant #3 stated the following to the surveyor: (a) Urine microscopic testing was performed in the laboratory; (b) The urine specimens were processed in the Hettich Zentrifuge Universal 320 centrifuge at a speed of 1500 rpm (revolutions per minute) for 5 minutes; (c) The centrifuge speed and timer were checked for accuracy annually by the hospital biomedical department (typically in August of each year). (2) The surveyor requested the records for speed and timer checks performed during 2018 and to date. The documentation for the checks that had been performed in August 2018 could not be retrieved. Technical consultant #3 explained the following to the surveyor: (a) The hospital biomedical department entered the results of the speed and timer checks into the computer. In addition, they documented the results on a sticker and affixed it to the centrifuge; (b) When the biomedical department performed the speed and timer checks for the current year, they would remove the sticker from the previous year and discard it; (c) The server crashed in IT (Information Technology) and the Biomedical Department lost the data for the 2018 speed and timer checks; (d) There were no records of the checks since the sticker that had been affixed to the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- centrifuge with the 2018 results had been discarded. (3) Therefore, the surveyor could not verify the speed and timer checks had been performed and were acceptable in 2018, since the record had not been maintained by the laboratory. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #2 and technical consultant #3, the laboratory failed to perform maintenance procedures as required by the manufacturer 3 of 4 months. Findings include: (1) At the beginning of the survey, technical consultant #3 stated to the following to the surveyor: (a) Urinalysis testing was performed using the Clinitek 500 analyzer; (b) The clinic was open and routinely performed patient testing Monday through Thursday. (2) Later during the survey, the surveyor reviewed the manufacturer's daily maintenance requirements located in Section 5 of the Operator's Manual, which stated "The fixed platform, moving table, reagent strip hold-down plate, push bar, and the liner should all be cleaned at least once each day or after running 300 strips, whichever is more frequent"; (3) The surveyor then reviewed maintenance records for September 2018, January 2019, July 2019, and November 2019. There was no evidence the daily maintenance had been performed on the following days for 3 of 4 months: (a) September 2018 - 13 of 15 days (days 04,05,06,10,11,12,13,19,20,24,25,26,27) (b) July 2019 - 17 of 18 days (days 01,02,03,08,09,10,11,15,16,17,18,22,23,24,25,30,31) (c) November 2019 - 14 of 15 days (04,05,06,07,11,12,13,14,18,19,20,21,25,26) (4) The surveyor reviewed the records with technical consultant #2 and technical consultant #3. Both stated the daily maintenance had not been documented as performed as indicated above. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2 and technical consultant #3, the technical consultant failed to ensure evaluations included all moderate complexity testing performed. Findings include: (1) At the beginning of the survey, technical consultant #3 stated to the surveyor urine microscopic and manual differential testing were performed in the laboratory; (2) The surveyor reviewed personnel records for 3 persons performing urine microscopic and manual differential testing during 2018 and to date (testing person #1, testing person #2, and technical consultant #3/testing person #3,). The records showed that annual competency evaluations had been performed as follows: (a) Testing Person #1 - Performed on 12 /27/18 and 11/20/19 (b) Testing Person #2 - Performed on 12/27/18 and 11/20/19 (c) Technical Consultant #3/Testing Person #3 - Performed on 12/27/18 and 12/06/19 (3) -- 2 of 3 -- There was no evidence the evaluations performed for the above persons, included an assessment of urine microscopic and manual differential testing; (4) The surveyor reviewed the findings with technical consultant #2, who stated the above evaluations did not include urine microscopic and manual differential testing. -- 3 of 3 --