Summary:
Summary Statement of Deficiencies D0000 An unannounced complaint investigation was conducted on 04/22/2021. Please see event VLJX11 for the full CMS-2567. Complaint intake TX00363887 was unsubstantiated. 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 surveyor observation, review of manufacturer's instructions, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions when using the TRUE METRIX glucometer for multiple patient use. The findings were: 1. Surveyor observation made on April 22, 2021 at 09: 20 hours in the laboratory found 1 TRUE METRIX glucometer. 2. Review of the manufacturer's instructions for the TRUE METRIX glucometer (RE4NPDO3) stated, "Multiple patient use devices such as blood glucose meters should be used on only one patient and not shared. If dedicating blood glucose meters to a single patient is not possible, the meters must be properly cleaned and disinfected after every use following the guidelines found in Meter Care, Cleaning/Disinfecting." 3. The laboratory was asked to provide documentation of following the manufacturer's requirements to clean and disinfect the glucometer after every use. No documentation was provided. 4. An interview with the Clinical Director on April 22, 2021 at 10:15 hours in Patient Exam Room #3 confirmed the findings. She confirmed that the glucometer is cleaned after each use but that it is not documented. II. Based on surveyor observation, review of manufacturer's instructions, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions for monitoring revised expiration dates for TRUE METRIX glucometer Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- test strips. The findings were: 1. Surveyor observation made on April 22, 2021 at 09: 20 hours in the laboratory found 1 opened vial of TRUE METRIX glucometer test strip available for patient use. Lot #ZX4177S Expiration Date: 06-15-2021 No open or revised expiration date 2. Review of the manufacturer's instructions for the TRUE METRIX glucometer (RE4NPDO3) stated, "Write date first opened on vial label. Discard vial and unused test strips if either 4 months after first opening or date printed next to EXP on vial label has passed, whichever comes first." and; "Caution! Use of test strips or control solution past the Expiration Dates may give incorrect test results. Discard out-of-date products and test with new products." 3. The laboratory was asked to provide documentation of the following the manufacturer's instructions to monitor revised expiration dates of TRUE METRIX test strips. No documentation was provided. 4. An interview with the Clinical Director on April 22, 2021 at 10:15 hours in Patient Exam Room #3 confirmed the findings. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the laboratory's records, and staff interview, it was revealed the facility failed to have documentation of enrolling in proficiency testing for 2020 and 2021. The findings were: 1. A review of the laboratory's records revealed the facility started performed moderate complexity testing on the Abbott i-STAT in July 2020. They performed testing utilizing the CHEM8+ cartridges which tested for the following regulated analytes: Sodium Potassium Cloride Total CO2 Glucose BUN /Urea Creatinine Hematocrit 2. The laboratory was asked to provide documentation of being enrolled for proficiency testing in 2020 and 2021 for the listed analytes. No documentation was provided. 3. An interview with testing personnel number 1 (as listed on Form CMS 209) on 04/22/2021 at 1600 hours confirmed the findings. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the Abbott i-STAT analyzer, review of laboratory records, and staff interview, it was revealed the laboratory failed -- 2 of 11 -- to have documentation of monitoring the temperature of shipments of cartridges as required by the manufacturer. The findings were: 1. A review of the manufacturer's instructions for the Abbott i-STAT (Art: 714258-00Q, Rev Date: 15-APR-2018) under the section titled "Cartridge and Test Information" revealed: "Verify Newly Received Cartridges and Control Materials Verify that the transit temperatures were satisfactory using the four-window temperature indicator strip included in the shipping container." 2. The laboratory was asked to provide documentation of verifying the temperature of each shipment of cartridges. No documentation was provided. 3. An interview with testing personnel number 1 (as listed on CMS 209) on 04/22/2021 at 1600 hours in her office confirmed the findings. 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 review of the laboratory's records and staff interview, it was revealed the laboratory failed to be in compliance with analytic systems. The findings were: 1. The laboratory failed to provide documentation of establishing and monitoring an acceptable room temperature (refer to D5413). 2. The laboratory failed to have documentation of performing verification studies (refer to D5421). 3. The laboratory failed to have documentation of performing calibration verification (refer to D5439). 4. The laboratory failed to have control procedures that monitored accuracy and precision (refer to D5441). 5. The laboratory failed to have documentation of performing quality control testing each day of patient testing (refer to D5447). 6. The laboratory failed to provide documentation of performing