Arcpoint Labs Of Rock Hill

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on lack of documentation and testing personnel interview, the laboratory failed to monitor and evaluate the overall quality of the general laboratory systems and correct identified problems for the Coronachek COVID-19 IgG/IgM test for 21 of 21 days reviewed (April 14, 2020 through May 5, 2020) (See D5209, D5291) 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 the lack of documentation and testing personnel interviews it was determined that the laboratory failed to establish written policies and procedures to assess the competency of the testing personnel who performed the Coronachek COVID-19 IgG/ IgM test. Findings include: 1. During the onsite complaint investigation on 05/05/2020, the laboratory failed to provide written policies and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- procedures to detail how the laboratory would assess the competency of the testing personnel conducting the Coronacheck COVID-19 IgG/ IgM test. 2. The Laboratory Director confirmed during an onsite interview on 05/05/2020 at 11:30 AM that the laboratory had been performing and reporting the Coronachek test since April 2020 and there were no policies or procedures for competency assessment and no records to document the competency of the testing personnel to ensure accurate reliable test results from April 2020 to May 2020. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of documentation and testing personnel interview, the laboratory failed to establish and follow quality assessment policies and procedures to monitor, assess, and correct problems identified with general laboratory systems of Coronachek COVID-19 IgG/ IgM test testing for 21 of 21 days reviewed (April 14, 2020 through May 5, 2020) . Findings include: 1. During an onsite complaint investigation on 05/05 /2020 there was no documented established quality assessment plan to address patient confidentiality, specimen identification and integrity, complaint investigations, communications, personnel competency, or proficiency testing performance available for review on the day of the survey. 2. Testing personnel confirmed during an onsite interview on 05/05/2020 at 11:30am that the laboratory did not have established protocols to evaluate general testing quality of Coronachek COVID-19 IgG/ IgM test in the laboratory for 21 of 21 days reviewed (April 14, 2020 through May 5, 2020). D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on lack of documentation and testing personnel interview, the laboratory failed to monitor and evaluate the overall quality of the preanalytic systems and correct identified problems for test requests and quality assessment for the Coronachek COVID-19 IgG/ IgM test for for 21 of 21 days reviewed (April 14, 2020 through May 5, 2020) (See D5305 and D5391) D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) -- 2 of 10 -- The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on the patient test requisition review and staff interview it was determined that the laboratory failed to ensure the test requisition solicited suitable identifiers of the authorized person requesting the test, specimen source, and time of specimen collection for 2 of 2 patients requisitions reviewed for the Coronachek COVID-19 IgG/ IgM test. Findings include: 1. During an onsite complaint investigation on 05/05 /2020, random patient test requisition review revealed that the laboratory test requisition did not document the following information for 2 of 2 patients reviewed: a. The name and address of the authorized person requesting the test. b. The address of the laboratory submitting the specimen c. The source of the specimen d. The time of specimen collection. 2. The laboratory director confirmed during an onsite interview on 05/05/2020 at 11:00am that the laboratory had been performing and reporting the Coronachek test since April 2020 and failed to ensure the test requisition solicited suitable identifiers of the authorized person requesting the test, specimen source, and time of specimen collection for 2 of 2 patients requisitions reviewed. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on the absence of laboratory policies and procedures and staff interview it was determined that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the preanalytic systems for Coronachek COVID-19 IgG/ IgM test for 21 of 21 days reviewed (April 14, 2020 through May 5, 2020). Findings include: 1. During an onsite complaint investigation on 05/05/2020, laboratory policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the immunology preanalytic systems were unavailable for review. 2. The laboratory director confirmed during an onsite interview on 05/05/2020 at 11:00am that policies and procedures for an ongoing mechanism to monitor, assess and correct preanalytic problems for the Coronachek COVID-19 IgG/IgM test had not been developed, approved, or maintained for 21 of 21 days reviewed (April 14, 2020 through May 5, 2020) . -- 3 of 10 -- D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on lack of documentation and testing personnel interview, the laboratory failed to ensure the overall quality of the analytic systems in the laboratory was monitored and evaluated for procedure manual, test temperatures, performance verification and establishment, control procedures, and quality assessment for the Coronachek COVID- 19 IgG/IgM test for 21 of 21 days reviewed (April 14, 2020 through May 5, 2020) . (See D5403, D5413, D5421, D5449, D5790 and D5791). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)