Chop A Division Of Rcca- Md

Summary Statement of Deficiencies 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 observation and interview, the laboratory did not provide the lot number and expiration date of the lyse and wash solutions used for testing on the hematology analyzer for 1 of 4 records requested, to ensure that an event such as a reagent recall may be investigated. Findings: 1. The laboratory did not provide the lot number and expiration dates for the hematology reagents for November 2022, to show that the records are maintained for the required two year retention. 2. During interview with the technical consultant at 11:00 am on 10/16/2024, the technical consultant stated that the analyzer will not operate without registering the in date reagents lot numbers, and that the analyzer stored the records for at least two years, but was unable to provide the November 2022 records to confirm this. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system 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 -- performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory did not document weekly reviews of Levey-Jennings charts from the hematology analyzer to monitor shifts and trends, as stated in the laboratory's written procedure. Findings: 1. The laboratory written procedure states that Levey-Jennings charts are reviewed weekly to detect shifts or trends of test results for each of the three levels of quality control reagents in use to check accuracy of the test system. The laboratory did not document these weekly reviews. 2. This was confirmed during interview with the technical consultant at 11:00 am on 10/16/2024. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and interview, the hematology laboratory did not perform a random review of five patient charts annually as stated in the written procedure. Findings: 1. The laboratory written procedure states that the laboratory conducts an annual review of five random patient charts to check the reliability of patient hematology test result entry and orders. The laboratory did not perform the annual reviews for 2023. 2. This was confirmed during interview with the technical consultant on 10/16/2024 at 11;00 am. -- 2 of 2 --

Summary Statement of Deficiencies 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 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 review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to retain the attestation worksheets for one of four PT events reviewed. Findings: 1. The PT records for 2022 and 2023 were reviewed for a total of four PT events. 2. The signed attestation statement documenting that PT samples were tested in the same manner as patient specimens was missing for one of the four PT events reviewed (2023 1st event). 3. During the survey on 04/28/2023 at 1:15 PM, the TC confirmed that the signed attestation statement was missing for one of four PT events reviewed. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Note: This is a repeat deficiency. The laboratory was cited during the recertification survey completed on 10/08/2021 for not retaining all hematology quality control (QC) results. The laboratory's

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory did not ensure that all the testing personnel who tested patient samples performed the PT. Findings: 1. The laboratory currently has 4 testing personnel listed on the "Laboratory Personnel Report (CMS-209)." 2. A review of PT attestation worksheets from 2019 through 2020 showed that 2 of 4 testing personnel did not perform PT for 6 of 6 PT events in hematology and coagulation; and 3. One of 4 testing personnel performed the chemistry PT for 8 of 8 PT events. 4. During an interview on 10/8/2021 at 10:00 AM, the TC confirmed that PT samples were not tested each year by all the staff who perform patient testing to ensure accurate and reliable patient test results. 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 laboratory record review and electronic communication with the technical consultant (TC), the laboratory failed to retain all analytic systems records for at least Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- 2 years. Findings: 1. In emails sent to the TC on 4/28/2021, 7/26/2021, 9/10/2021, 9/21 /2021, 9/24/2021, and 9/29/2021 the surveyor requested documents needed to complete a remote survey of the laboratory. 2. Record review showed that the laboratory did not submit a procedure for performing quality assessment reviews. 3. Record review showed that the laboratory did not submit calibration records for the Medica EasyRA chemistry analyzer. In an email on 10/1/2021 the TC stated, "EasyRA requires calibration current,etc for tests to be performed HOWEVER, was unable to locate Cal Verificaton reports to send to you." 4. The laboratory's "Quality Control" procedure manual instructs the testing person to document

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the performance summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for routine chemistry testing, in which the laboratory is certified under CLIA. (Refer to D2096) D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 -- 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 review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for chemistry testing. The laboratory failed to attain a score of 80% for each analyte in the test event. Findings: 1. American Proficiency Institute 2019 1st event Chloride (CL) 60% 2. American Proficiency Institute 2019 1st event sodium 0% 3. American Proficiency Institute 2019 3rd event Calcium (CA, total) 60% 4. American Proficiency Institute 2019 3rd event sodium 60% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the performance summery from American Proficiency Institute proficiency testing program, the laboratory failed to successfully participate in the API PT program for routine chemistry. The following analyte was noted as failed in the 2019 first and third event. Findings: 1. American Proficiency Institute 2019 1st event sodium 0% 2. American Proficiency Institute 2019 3rd event sodium 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the performance summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory director failed to ensure the laboratory successfully participated in the API PT program for routine chemistry testing, in which the laboratory is certified under CLIA. (Refer to D2087 and D2096) 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

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data, onsite proficiency testing data , and interview of the technical consultant (TC), the laboratory failed to successfully participate in the American Proficiency Institute proficiency testing program for hematology testing, in which the laboratory is certified under CLIA (Refer to D2131) D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing data, onsite proficiency testing data , interview of the technical consultant (TC) and the testing person (TP), the laboratory failed to successfully participate in the American Proficiency Institute proficiency testing (PT) program for hematology testing, in which the laboratory is certified under CLIA. Findings: 1. The laboratory did not submit PT samples for the 2018 1st and 2nd event hematology. 2. The TC and the TP stated that the samples were not sent by the PT agency and therefore were not completed. 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 observation of the chemistry analyzer around 12 Noon, interview with the technical consultant, and the testing person, the laboratory failed to ensure that the chemistry analyzer internal temperature was within the manufacturers optimal testing range for delivering accurate and reliable patient test results (Refer to D5413); And evaluations of the analyzer analytic quality and