Junction Clinic Pc

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Medical Assistant, the laboratory failed to ensure safety procedures were established and observed to ensure safety from biohazardous materials by storing food in the laboratory refrigerator. Findings include: 1. The surveyor observed cheese wrapped in paper resting on hematology controls containing blood, jars of food, and a molding vegetable in the refrigerator on 11/7/22 at 10:19 am. 2. A review of the laboratory's procedures revealed a lack of safety procedures established. 3. An interview on 11/7/22 at 10:22 am with the Medical Assistant confirmed food to be present in the laboratory refrigerator. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 During a recertification survey on October 5, 2022, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1250 Condition: Analytic systems 42 CFR 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 record review and an interview with the Technical Consultant (TC), the laboratory failed to establish policies and procedures to assess the competency of personnel serving the roles of Clinical Consultant and Technical Consultant for 2 (October 2020 to October 2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's personnel records revealed the most recent competency assessments for the Clinical and Technical Consultants were dated 8/7/20 and 8/6/20 respectively. 2. The surveyor requested the laboratory's policy or procedure for assessing the competency of the Clinical and Technical Consultants on 10/5/22 at 11:28 am and it was not made available. 3. An interview on 10/5/22 at 11:36 am with the TC confirmed the laboratory had not established a policy or procedure for assessing competency of the Clinical and Technical Consultant. 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 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 -- 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 record review, observations, and interviews, the laboratory failed to follow its policy to perform calibration verification at least every six months for Prostate Specific Antigen (PSA) and Testosterone analytes (Refer to D5401), failed to perform control testing each day of patient testing for Prostate Specific Antigen (PSA) and Testosterone analytes (Refer to D5445), and failed to ensure the results of Prostate Specific Antigen (PSA) and Complete Blood Count (CBC) control testing met the acceptability criteria before reporting patient results (Refer to D5481). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on record review and observation, the laboratory failed to follow its policy to perform calibration verification at least every six months for Prostate Specific Antigen (PSA) and Testosterone analytes for 2 (October 2020 to October 2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Lab Policies" revealed a section stating, "Calibration verification must be done every 6 months or as needed after service or change of reagents." 2. A review of the laboratory's "Calibration Verification" forms for PSA and Testosterone testing performed on the NanoEnTek Frend analyzer revealed handwritten documentation of calibration verification results for the following dates: a. 1/20/21 b. 10/21/21 c. 1/20/22 d. 7/20/22 3. The surveyor requested the instrument data from the calibration verification events listed above on 10/5/22 at 1:20 pm and the documents were not made available. 4. A review of the NanoEnTek Frend analyzer printouts revealed a lack of documentation for any PSA or Testosterone calibration verification testing performed on the dates listed above. 5. A review of the NanoEnTek Frend analyzer stored data revealed a lack of documentation for any PSA or Testosterone calibration verification testing performed on the dates listed above. 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 specimen collection staff, the laboratory failed to ensure blood collection tubes had not exceeded their expiration date for 23 of -- 2 of 6 -- 23 sodium citrate BD Vacutainer tubes present in the laboratory's collection area. Findings include: 1. The surveyor observed 23 BD Vacutainer sodium citrate tubes in stock in the laboratory's collection area on 10/5/22 at 9:42 am and all had exceeded their expiration dates: a. Lot 9220387 with the expiration date of 5/31/20, three tubes present. b. Lot 0345722 with the expiration date of 9/30/21, three tubes present. c. Lot 1288649 with the expiration date of 7/31/22, 17 tubes present. 2. An interview with specimen collection staff on 10/5/22 at 9:56 am revealed the laboratory used the sodium citrate tubes to collect specimens for referral testing. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review, observation, and interview with the Technical Consultant (TC), the laboratory failed to perform control testing each day of patient testing for Prostate Specific Antigen (PSA) and Testosterone analytes for 20 (10/01/2020, 10/22 /2020, 10/29/2020, 12/03/2020, 04/16/2020, 06/11/2021, 01/28/2022, 02/22/2022, 02 /25/2022, 03/04/2022, 03/18/2022, 03/25/2022, 04/08/2022, 04/15/2022, 04/29/2022, 06/28/2022, 08/03/2022, 08/19/2022, 08/26/2022, and 09/30/2022) of 27 patient testing dates from October 2020 to October 2022. Findings include: 1. A review of the laboratory's "Lab Policies" revealed a section stating, "Chem, Hem, RIA- run minimum 2 controls each day of run. If both controls not in range, do

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 CMS database and review of the American Association of Bioanalysts (AAB) proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte: urea nitrogen (BUN). Findings include: Review of the CMS database and the AAB proficiency testing reports showed unsatisfactory performance for two of two proficiency testing events for the chemistry analyte: BUN. Refer to D2087 and D2096. D2087 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(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 review of the CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to attain a score of at least 80% of acceptable responses for the analyte: urea nitrogen (BUN), which is unsatisfactory performance for the testing events. Findings include: BUN PT Event Score 1st event 2018 40% 3rd event 2017 40% 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 CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte urea nitrogen (BUN) in two of two consecutive testing events. Findings include: Unsatisfactory performance for two of two consecutive proficiency testing events constitutes unsuccessful performance for BUN: BUN PT event Score 1st event 2018 40% 3rd event 2017 40% -- 2 of 2 --