Sc Medical Inc

Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on the request for patient/test records, review of five (5) randomly chosen patients' test requisitions and test results, and interviews with the technical consultant (TC) and testing personnel (TP); the laboratory failed to record the time patient samples were received and tested. Findings include: 1. The laboratory was unable to provide the complete test results according to the test ordered and documentation of the reason why the testing was performed three days later for one (1) out of five (5) randomly chosen patient samples. 2. The TC confirmed on March 6, 2024 at approximately 12:00 p.m. that the laboratory did not document the reason the requisition did not match the time the specimens were received and tested. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on the surveyors' observation during the laboratory tour and interview with the technical consultant (TC) the laboratory failed to label quality control reagents used for hematology. The findings included: 1. Based on the surveyor's observation during 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 -- the laboratory's tour on March 6, 2024 at approximately 12:15 p.m.; no opening, preparation, or expiration date labels were used or documented for the quality control reagents used for hematology sample processed daily. 2. The TC affirmed in an interview conducted 3/6/2024, at approximately 12:30 p.m. that the reagents mentioned in statement 1 were not labeled with the opening, preparation, and expiration dates or documented. 3. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed approximately 2,700 hematology samples. 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 review of the laboratory's procedure manual, lack of documentation, the surveyor's observation, and interview with the laboratory's technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed to perform and document maintenance and calibration as defined by the manufacturer and with at least the frequency specified by the manufacturer for the laboratory's small equipment. The findings included: 1. The laboratory's standard operating procedure (SOP) indicated that preventive maintenance and calibration be performed on all equipment and instruments used in the laboratory. 2. The TC and TP confirmed on March 6, 2024, at approximately 12:30 p.m. that the laboratory failed to follow the manufacturer's instructions on preventive maintenance and calibration of small equipment such as timers. 3. According to the test volume declared by the laboratory on 2/20/2024 the laboratory performs approximately 2,700 hematology diagnostic tests annually. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (E) The laboratory director must-- (E)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on observation, review of the laboratory records, and interview with the technical consultant and testing personnel it was determined that the laboratory director failed to be responsible for the overall operation, including, but are not limited to ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. The findings included: D5313, D5415, and D5429. -- 2 of 2 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) evaluation from American Proficiency Institute (API), PT sample test records and interview with the laboratory technical consultant on November 3, 2021 at 12:48 pm, the laboratory failed to attain a score of at least 80 percent of acceptable responses for Leukocyte count, Erythrocyte count, Hemoglobin and Hematocrit at the 2nd event of 2021. The findings include: 1. The laboratory performed complete blood count (CBC) using an automated CDS Medonic instrument. To verify its test accuracy, the laboratory participated in API PT testing for the year of 2021. However, it received a score of 20% at the 2nd event for the following analytes: Leukocyte count, Erythrocyte count, Hemoglobin and Hematocrit, resulting in an unsatisfactory analyte performance for the event. Therefore, the failure in the PT event suggesting that the patients' results reported during the PT event period might had not been accurate and thus causing patient harm. 2. The laboratory technical consultant on November 3, 2021 at 12:48 pm, affirmed that the laboratory had received a score of 20% at the 2nd event for the following analytes: Leukocyte count, Erythrocyte count, Hemoglobin and Hematocrit. 3. The laboratory's testing declaration form, signed by the laboratory Director on 11/01 /2021, stated that the laboratory performs 2,700 CBC tests, annually. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) evaluation from American Proficiency Institute (API), PT sample test records and interview with the laboratory technical consultant on November 3, 2021 at 12:48 pm, the laboratory failed to take any remedial action and re-train its testing person #1 after receiving an unsatisfactory score of 20 percent for Leukocyte count, Erythrocyte count, Hemoglobin and Hematocrit at the 2nd event of 2021. The findings include: 1. The laboratory performed complete blood count (CBC) test for PT samples using an automated CDS Medonic instrument. The laboratory investigated the PT failure, however, was not able to find out the reason. Instrument print out, ran on 7/24/2021, showed "AL" flag next to the RBC and HGB results for the PT samples HSY-06, HSY-07 and HSY-09. The laboratory's procedure instructs to dilute the sample and rerun, but the testing person #1 failed to do so. That could be the reason of the PT failure. However, laboratory's failure to find out the problem resulted lack of any remedial action or re-training the testing person involved. Therefore, the testing person #1's failure to follow the laboratory procedure suggesting that the patients' results reported by the testing person #1 might had not been accurate and thus causing patient harm. 2. The laboratory technical consultant on November 3, 2021 at 12:48 pm, affirmed that the laboratory testing person #1 did not follow the laboratory's procedure to run PT samples and the lab did not take any remedial action due to the failure to identify the problem. 3. The laboratory's testing declaration form, signed by the laboratory Director on 11/01/2021, stated that the laboratory performs 2,700 CBC tests, annually. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) evaluation from American Proficiency Institute (API), PT sample test records and interview with the laboratory technical consultant on November 3, 2021 at 12:48 pm, the laboratory director failed to ensure compliance with the applicable regulations. The findings include: See D2121 and D2128. D6019 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 4 -- CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on reviews of the third quarter (Q3-2016) and third quarter (Q3-2018) of the American Proficiency Institute (API) proficiency testing records, random patient test results, and interview with the testing personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event. The findings included: a. API reported the following unsatisfactory proficiency testing scores. Analyte:Score: Event/Year: Gran 20% Q3- 2016 Lymph 20% Q3-2016 Mono 20% Q3-2016 Neut/ Gran 0% Q3-2018 Abbreviations: Neut/Gran= Neutrophils/Granulocytes Mono= Monocyte Lymph= Lymphocytes b. For ten (10) out of ten (10) random patient test results reviewed covering period from 10/12/2016 to 12/5/2018, the laboratory analyzed and reported White Blood Cells (WBC) Differential which included the above anlytes that failed the proficiency testing. c. The testing personnel confirmed (3/12/2019, 12:45) that the laboratory received the above unsatisfactory proficiency testing scores. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved