West Carroll Medical Clinic

Summary Statement of Deficiencies D0000 A Certification Survey was performed on January 15, 2021 at West Carroll Medical Clinic, CLIA ID # 19D0464390. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 review of the laboratory's CMS form, personnel records, and interview with personnel, the laboratory failed to ensure the Laboratory Director assessed competency for two (2) of two (2) Technical Consultants reviewed. Findings: 1. Review of the laboratory's CMS-209 (Laboratory Personnel Report) revealed the following personnel serves as Technical Consultants: a) Personnel 4 b) Personnel 5 2. Review of the laboratory's "Personnel Requirements" policy under "Job Description: Medical Director/Laboratory Director" revealed the following responsibility: a) Monitoring the continuing education/competency of the Compliance Specialist and Technical Consultant initially and annually thereafter. 3. Review of the personnel records revealed the laboratory did not have a documented 2019 and 2020 annual competency assessment for their duties as Technical Consultant for the following two (2) of two (2) personnel: a) Personnel 4 b) Personnel 5 4. In interview on January 15, 2021 at 10:40 am, Personnel 5 stated the Technical Consultant competency evaluation policy should be to perform assessment once upon hire until the change of personnel but the policy has not been updated to state the frequency. Personnel 5 confirmed the Laboratory Director did not perform an annual competency for the Technical Consultants. 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 -- D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on policy and procedure manual review and interview with personnel, the laboratory failed to have current policies and procedures approved and signed by the current Laboratory Director. Findings: 1. Review of the laboratory's policy and procedure manual on January 15, 2021 at 10:35 am revealed the following policies which is not an inclusive list were not approved and signed by the current Laboratory Director: a) Personnel Requirements b) Personnel Assessment c) BinaxNow COVID- 19 Ag Card 2. In interview on January 15, 2021 at 11:00 am, Personnel 5 stated that the previous Laboratory Director retired in 2019 and the current director has approved and signed some but not all of the policies and procedures in use. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were established and maintained. Findings: 1. The laboratory failed to ensure the Laboratory Director assessed competency for two (2) of two (2) Technical Consultants reviewed. Refer to D5209. 2. The Technical Consultant failed to perform a competency assessment at least semi-annually during the first year for one (1) testing personnel. Refer to D6053. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure an approved policy and procedure manual was available to all personnel. Refer to D5407. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Consultant failed to perform a competency assessment at least semi-annually during the first year for one (1) testing personnel. Findings: 1. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed the laboratory has three (3) testing personnel. 2. Review of personnel records revealed the laboratory performed an initial evaluation on Personnel 6 on September 20, 2019. 3. Further review of personnel records revealed the laboratory did not have documentation of a semi-annual competency assessment for Personnel 6 which was due in March 2020. 4. In interview on January 15, 2021 at 10:17 am, Personnel 5 who serves as the Technical Consultant stated she forgot to perform the six (6) month evaluation for the newly hired personnel. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A PT Desk Review was performed on June 18, 2020. West Carroll Medical Clinic, CLIA ID 19D0464390, was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 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 proficiency testing (PT) results from the CASPER 155D report, the laboratory failed to successfully participate in proficiency testing for Hematology. Refer to D2130. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) results from the CASPER 155D report, the laboratory failed to achieve a score of at least 80% for White Blood Cells Differential (WBC DIFF) in two consecutive events, resulting in an initial unsuccessful performance. Findings: 1. Review of the CASPER 155D report for PT results revealed the laboratory received the following scores for WBC DIFF resulting in an initial unsuccessful performance: a) 2019 Event 2: 33% b) 2020 Event 1: 13% 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 record review, the Laboratory Director failed to provide overall management and direction for the laboratory. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on record review, the Laboratory Director failed to ensure that proficiency testing results are satisfactory as required. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification Survey was conducted June 28, 2018 at West Carroll Medical Clinic - CLIA ID # 19D0464390. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. 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 with personnel, the laboratory failed to ensure supplies have not exceeded their expiration date. Findings: 1. Observation by surveyor during laboratory tour on June 28, 2018 revealed the following expired items: * Cabinet located in laboratory: a) two (2) purple microtainers - Lot 15H4004 Exp 08 /17 * Phlebotomy Tray located on laboratory counter a) eight (8) purple microtainers - Lot 15C4238 Exp 04/17 b) four (4) purple microtainers - Lot 15K4044 Exp 11/17 c) ten (10) purple microtainers - Lot 15H4044 Exp 08/17 d) three (3) purple microtainers - Lot 12I4060 Exp 11/14 e) one (1) purple microtainer - Lot 14K4166 Exp 12/16 f) one (1) purple microtainer - Lot 13K4385 Exp 01/16 g) one (1) purple microtainer - Lot 13F4411 Exp 07/15 2. In interview on June 28, 2018 at 9:40 am, Personnel 2 stated she was unaware of expired supplies. Personnel 2 confirmed the supplies were expired. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- 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 -- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to verify the means for Quality Control (QC) material for Hematology testing prior to use. Findings: 1. Observation by surveyor during laboratory tour on June 28, 2018 revealed the laboratory utilizes the Horiba ABX Micros 60 analyzer with Horiba Medical Minotrol 16 Tri-Level Controls for Complete Blood Count (CBC) testing. 2. Review of the Minotrol 16 Tri-Level Controls package insert under "Performance and characteristics" section revealed "Assay values on a new lot of control should be confirmed before it is put into routine use. The laboratory recovered mean should be within the assay range." 3. Review of the laboratory's policy and procedure manual revealed the laboratorydid have a policy for the new lots of controls which stated "Verification of QC ranges given should be done prior to putting a new lot in use." 4. Review of the laboratory's QC records revealed the laboratory did not have documentation of verification of new lot QC means prior to use or runs concurrent with previous lot for the following lot numbers: Lot # MX409 Exp 3/5/18 Lot # MX410 Exp 5/5/18 Lot # MX411 Exp 7/5/18 5. In interview on June 28, 2018 at 10: 30 am, Personnel 2 stated the testing personnel should be verifying controls but she could not find any documentation to support. Personnel 2 confirmed the laboratory did not verify the means for new lots of QC. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to follow established policies to monitor, assess, and correct quality issues in Analytic Systems. Findings: 1. Review of the laboratory's Quality Assurance (QA) form revealed the laboratory did have a Hematology QA monitor in place for Lot to Lot verification; However, the monitors did not identify and correct the issue for the following: a) The laboratory failed to verify the means for Quality Control (QC) material for Hematology testing prior to use. Refer to D5469. 2. In interview on June 28, 2018 at 11:45 am, Personnel 2 confirmed the QA monitors in place did not correct the above issues. D6020 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure that the quality control was maintained to assure quality laboratory services were provided. Refer to D5469. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on observation, record review and interview with laboratory personnel, the Laboratory Director failed to ensure that a quality assessment (QA) program was established and maintained to assure the quality of laboratory services provided. Refer to D5791. -- 3 of 3 --