Summary:
Summary Statement of Deficiencies D0000 A Validation survey was performed at Alexandria Women's Center, CLIA ID # 19D1007477, on December 12, 2022 through December 13, 2022. Alexandria Women's Center 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 D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: I. Based on observation by surveyors, review of the operator's manual and laboratory maintenance records as well as interview with personnel, the laboratory failed to perform the weekly maintenance for the Piccolo Xpress chemistry analyzer as required by the manufacturer for one (1) of fifty (50) weeks reviewed. Findings: 1. Direct observation by surveyors during the laboratory tour on December 12, 2022 at 1: 30 pm revealed the laboratory utilizes the Piccolo Xpress analyzer for the following waived chemistry testing: Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, Calcium, Blood Urea Nitrogen, Creatinine, Alkaline Phosphatase, Alanine Transaminase, Aspartate Transferase, Total Bilirubin, Albumin, Total Protein, Total Cholesterol, Low Density Lipoprotein, High Density Lipoprotein, Triglycerides 2. Review of the operator's manual for the Piccolo Xpress Chemistry analyzer revealed the following weekly maintenance: a) Clean the analyzer's external case and display at least weekly. Inspect the instrument casing during cleaning to ensure it is free of damage or cracks. 3. Review of the laboratory's maintenance records for the Piccolo Xpress chemistry analyzer from January 1, 2022 through December 13, 2022 revealed 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 -- the laboratory did not perform the weekly maintenance for the week of November 21, 2022 through November 25, 2022. 4. In interview on December 13, 2022 at 9:30 am, Testing Personnel 6 confirmed the weekly maintenance was not performed for the identified week in November 2022. II. Based on observation by surveyors and interview with personnel, the laboratory failed to ensure supplies did not exceed expiration dates set by the manufacturer. Findings: 1. Direct observation by surveyors during the laboratory tour on December 12, 2022 at 1:30 pm revealed the following expired items: a) Hemocue Cleaner swabs Lot 1195203902 Expiration 9/20/22 Quantity: 5 swabs 2. In interview on December 12, 2022 at 1:45 pm, Testing Personnel 6 confirmed the identified supplies had exceeded the expiration date. 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 procedures 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 written instructions for the investigation of complaints. 2. In interview on December 12, 2022 at 4:10 pm, Testing Personnel 6 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures 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 policies revealed the laboratory did not have written instructions 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 December 12, 2022 at 4:10 pm, Testing Personnel 6 confirmed the laboratory did not 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. -- 2 of 13 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, and interview with personnel, the laboratory failed to establish written policies and procedures to assess competency for testing personnel. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include frequency of performance and the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing 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. In interview on December 12, 2022 at 4:10 pm, Testing Personnel 6 confirmed the laboratory did not include a competency assessment policy for testing personnel. 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 surveyors, review of laboratory policies and records as well as interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: a) The laboratory failed to ensure maintenance was performed as required for the Cepheid GeneXpert for three (3) of twelve (12) months reviewed. Refer to D5429. b) The laboratory failed to establish procedures for monitoring timer function checks utilized for kit testing prior to patient testing. Refer to D5435. c) The laboratory failed to perform quality control (QC) for the Cepheid GeneXpert analyzer every thirty (30) days per policy for two (2) of twenty four (24) months reviewed. Refer to D5445. d) The laboratory failed to perform