Green Clinic Pulmonary Lab

Summary Statement of Deficiencies D0000 A Certification Survey was performed at Green Clinic Pulmonary Laboratory - CLIA # 19D0880378 on March 21, 2022. Green Clinic Pulmonary Laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 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 by surveyor, review of laboratory policy and procedure, quality control and patient records as well as interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to have a complete policy and procedure manual. Refer to D5403. 2. The laboratory failed to have a complete Individualized Quality Control Plan (IQCP) to support the reduction in frequency of quality control (QC) for Arterial Blood Gas testing. Refer to D5445. 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, 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 -- 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)

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on January 9, 2018 at Green Clinic Pulmonary Lab - CLIA # 19D0880378. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard level deficiencies were cited. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it documents all complaints and problems reported to the laboratory. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the manual did not include written policy or procedure detailing how the laboratory is to address, document, and handle complaints or problems reported to the laboratory. 2. Interview with Personnel 2 on January 9, 2018 revealed she was unaware of all the policies and procedures that were required. Personnel 2 confirmed the laboratory did not have a complete policy and procedure manual. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it documents all complaints and problems reported to the laboratory. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 2. Interview with Personnel 2 on January 9, 2018 revealed she was unaware of all the policies and procedures that were required. Personnel 2 confirmed the laboratory failed to have a complete policy and procedure manual. 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 laboratory policy and procedure manual, and interview with personnel, the laboratory failed to establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to establish written policies and procedures that include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel involved in any phase of laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. Interview with Personnel 2 on January 9, 2018 confirmed the laboratory failed to have a detailed written policy and procedure that included the six (6) mandated items. 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 review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a laboratory policy and procedure manual that contained complete policies and procedures. Findings: 1. Review of the laboratory policy and procedure manual revealed the laboratory failed to have policies -- 2 of 3 -- and procedures for: Proficiency Testing (PT): a) Ordering and ensuring that you are enrolled for Proficiency Testing. b) What to do when you receive samples from the PT Provider. c) How to handle the samples; who will test, when to test, how do you assure no inter and intra laboratory communication takes place d) How to record results to send into the PT Provider to be scored. e) What records to maintain. f) How to evaluate when you receive your scores from the PT Provider. g) what steps to take if