Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the Technical Supervisor (TS) #1, the Laboratory Director (LD) failed to sign the API PT attestation statement documents from 2019 and 2020. Findings include: 1. On the day of survey, 09/25/2020, review of API PT records revealed, the following API PT attestation statement documents were not signed by the LD: - 2019, Event #1, Event #2, and Event #3: Hematology/coagulation. - 2020, Event #1 and Event #2: Hematology/coagulation - 2020, Event #1: Miscellaneous Chemistry. 2. The TS #1 confirmed on 09/25/2020 at 12:10 p.m. the findings above. 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 lack of competency assessment records and interview with the Technical Supervisor (TS) #1, the Laboratory failed to assess the competency of 1 of 3 testing personnel (TP) (on the CMS-209 form listed as testing personnel 1) who performed tests in the specialities of Hematology, Coagulation, Chemistry, and Urinalysis for 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 -- 2018, 2019, and 2020 Findings include: 1. On the day of survey, 09/25/2020, the TS could not provide competency assessment records for TP #1 from 07/12/2018 to the date of survey. 2. The Technical Supervisor confirmed the finding above on 09/10 /2020 at 12:15 p.m. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of i-STAT Protime (PT)/INR policy, review of Quality Control (QC) records and interview with the Technical Supervisor (TS) #1, the laboratory failed to perform two control materials of different concentrations each day of patient testing for i-STAT PT/INR cartridge in 2019 and 2020. Findings include: 1. The i-STAT Protime/INR policy states, "Liquid QC is performed monthly". 2. On the day of survey, 9/25/2020, review of i-STAT PT/INR QC records revealed, the laboratory did not perform two levels of control material each day of patient testing for the i-STAT Protime/INR tests analyzed in 2019 and 2020. 3. In 2019, 50 PT/INR tests were analyzed. 4. In 2020 (01/01/2020 to 09/25/2020), 34 PT/INR tests were analyzed. 5. The TS #1 confirmed the findings above on 09/25/2020 ay 10:45 am. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of urine sediment microscopic examination quality control (QC) records, review of Urine Microscopic Procedure, and interview with Technical Supervisor (TS) #1, the laboratory failed to perform QC each day of patient testing for urine microscopic examinations from 2019 to the day of survey. Findings Include: 1. The Urine Microscopic Procedure (page 4) point 8 stated : "Quality Control: Not applicable". 2. In 2019, 144 urine microscopic examinations were analyzed. 3. In 2020 (01/01/2020 to 09/25/2020), 118 urine microscopic examinations were analyzed. 4. The TS #1 confirmed on 09/25/2020 around 11:15 am, that QC was not performed for urine microscopic examinations from 01/01/2019 to 9/25/2020. 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 -- 2 of 4 -- 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 review of the General Oversight Procedure, review of the laboratory General Oversight Report records and interview with Technical Supervisor (TS) #1, The laboratory failed establish a General oversight procedure in January of 2019 and follow the General oversight procedure for 4 of 9 months in 2020. Findings include: 1. The laboratory's General Oversight Procedure (page 4) under frequency states: " The Medical Director and Laboratory Manager shall meet: At least one time per month" was establish in May of 2019. 2. On the day of survey 09/25/2020, review of the General Oversight Procedure revealed, patient testing began on January 2019 and the policy was not established until May of 2019. 3. Review of the General Oversight Report records revealed, the General Oversight Reports were not documented for 4 out of 9 months in 2020 (February, March, May, and July). 4. The TS #1 confirmed the findings above on 9/25/2020 at 12:15 p.m. 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