Summary:
Summary Statement of Deficiencies D0000 An Initial/Complaint survey was performed at Cypress Family Medicine, CLIA ID # 19D2233879, on September 29, 2021. Cypress Family Medicine was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic Systems 42 CFR 493.1290 CONDITION: Post Analytic Systems 42 CFR 493.1441 CONDITION: Laboratories Performing High Complexity Testing; Laboratory Director 42 CFR 493.1487 CONDITION: Laboratories Performing High Complexity Testing; Testing Personnel 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 review of the laboratory's policies and interview with personnel, the laboratory failed to have a system for handling complaints and problems reported to the laboratory. Findings: 1. Review of the laboratory's policies revealed the laboratory did not have a written procedure for reporting complaints, including who is responsible for handling. 2. In interview on September 29, 2021 at 1:07 pm, the Laboratory Director confirmed the laboratory did not have a written procedure for reporting/handling complaints. 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 13 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and interview with personnel, the laboratory failed to have a system in place to ensure that the documentation of communication problems are reported to the laboratory. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory did not 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. In in interview on September 29, 2021 at 1:07 pm, the Laboratory Director confirmed the laboratory failed to have a communication policy in place. 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 policies and interview with personnel, the laboratory failed to establish written policies and procedures to assess competency assessment policies for testing personnel. Findings: 1. Review of the laboratory's polices revealed the laboratory did not have a written policy for assessing the competency of personnel performing laboratory testing that included frequency of performance and the following six (6) procedures as a minimal requirement: 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. In interview on September 29, 2021 at 1:07 pm, the Laboratory Director confirmed the laboratory does not have a competency assessment policy for Testing Personnel. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the laboratory's records and interview with laboratory personnel, the laboratory failed to verifiy the accuracy of the performance of Live Blood Cell Analysis testing at least twice per year. Findings: 1. -- 2 of 13 -- Observation by surveyor during the laboratory tour on September 29, 2021 at 1:07 pm revealed the laboratory utilizes the American Biologics Bradford Microscope along with a BVPM-8e Fiber optic Controller for Live Blood Cell Analysis testing. 2. Review of the laboratory's policy manual revealed the laboratory did not have written, detailed instructions for verifying the accuracy of the performance of Live Blood Cell Analysis testing at least twice annually. 3. In interview on September 29, 2021 at 1:07 pm, the Laboratory Director confirmed she did not verify the accuracy of Live Blood Cell Analysis testing of patients at least twice per year. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy manual and interview with personnel, the laboratory failed to establish detailed, written instructions for monitoring, assessing, and correcting problems identified in the General Laboratory Systems. Findings: 1. Review of the laboratory policy manual revealed the laboratory did not have detailed instructions to assess problems found in the General Laboratory Systems for the following: 1. The laboratory failed to have a system for handling complaints and problems reported to the laboratory. Refer to D5205. 2. The laboratory failed to have a system in place to ensure that the documentation of communication problems are reported to the laboratory. Refer to D5207. 3. The laboratory failed to establish written policies and procedures to assess competency assessment policies for testing personnel. Refer to D5209. 4. The laboratory failed to verifiy the accuracy of the performance of Live Blood Cell Analysis testing at least twice per year. Refer to 5215. 2. In interview on September 29, 2021 at 1:07 pm, the Laboratory Director confirmed the laboratory did not establish policy and procedures for monitoring, assessing and correcting problems in General Laboratory systems. 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, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401. 2. The laboratory failed to establish a complete policy and procedure manual. Refer to D5403. 3. The laboratory failed to establish performance specifications for Live Blood Cell Analysis testing. Refer to D5423. 4. The laboratory failed to establish -- 3 of 13 -- quality control requirements and the frequency of performance for Live Blood Cell analysis testing. Refer to D5445. 5. The laboratory failed to establish procedures to monitor, assess, and correct problems, identified with the analytic system. Refer to D5791. 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 manual and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy manual revealed the laboratory did not have written and detailed policies and procedures that included the following: a)