Advanced Surgical Technology

Summary Statement of Deficiencies 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 laboratory records and interview with the laboratory representative; the laboratory failed to enroll in appropriate proficiency testing (PT) challenges for eight of eight iStat Chem 8+ regulated analytes performed (Chloride, Creatinine, Glucose, Potassium, Sodium, Urea Nitrogen (BUN), Hematocrit, and Hemoglobin) in 2021 through date of survey (11-07-2023). Findings Include: 1. Review of the laboratory's policy and procedure manual identified the test menu: Chem 8+ - Sodium, Potassium, Chloride, Glucose, Calcium (iCA)*, Total Carbon Dioxide (TCO2)*, BUN, Creatinine, Hematocrit, and calculated Anion Gap* and Hemoglobin (*=non-regulated analytes). 2. Interview with the laboratory representative, on 11-07-23 at 11:25 am, stated that patient testing started on 10-04- 2021. 3. Review of American Proficiency Institute (API) PT records revealed the laboratory failed to enroll for the correct five challenges, three times per year as required per 493.801 for eight of eight Chem 8+ regulated analytes performed in 2021 through the date of survey (11-07-23). 4. Interview with the laboratory representative, on 11-07-2023, at 11:29 am, confirmed the above findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 records, lack of documentation, and interview with the laboratory representative; the laboratory failed to have a formal competency policy /procedure in place to assess employee competency as required per 493.1235. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the lack of an appropriate competency assessment policy/procedure in place as required per 493.1235. 2. On survey date 11-7-2023, at 10:55 am, the laboratory representative confirmed the laboratory failed to have a formal competency policy /procedure in place to assess employee competency. 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 record review, lack of documentation, and an interview with the laboratory representative; the laboratory failed to maintain analytic system performance as required by 493.1250. First, the laboratory failed to monitor and document laboratory and manufacturer temperature requirements (see 5413). Secondly, the laboratory failed to verify performance for 10 out of 10 tested analytes (see 5421 and 5439). Lastly, the laboratory failed to meet the criteria for acceptability of quality control results prior to reporting patient test results (see 5481). D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and an interview with the laboratory representative; the laboratory failed to monitor and document manufacturer's required conditions essential for proper temperature of testing environment to ensure accurate -- 2 of 7 -- and reliable test system operations and results as required per 493.1252 for seven of seven patient testing dates reviewed. Findings include: 1. Review of the laboratory procedure manual stated on page one, under "Supplies and Storage Requirements" the following: "Cartridges must be at room temperature (18-30 C or 64-86 F) prior to use. Allow 5 minutes for an individual cartridge and one hour for a box of cartridges to come to room temperature." 2.The facilities lack of ability to provide the surveyors with required room temperature monitoring as per 493.1252 for seven of seven patient testing dates reviewed (11-23-2021, 04-05-2022, 07-12-2022, 09-16-2022, 01-17- 2023, 06-21-2023, and 10-18-2023). 3. On survey date 11-7-2023, at 3:02 pm, the laboratory representative confirmed the laboratory failed to be able to provide room temperature monitoring documentation. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory representative, the laboratory failed to demonstrate that it can obtain accuracy, precision, reportable range, and verification of reference intervals for ten out of ten analytes reported on the iSTAT 1 system using the Chem 8+ and Activated Clotting Time (ACT) cartridges for results comparable to those established by the manufacturer as required per 493.1253. Findings include: 1. Review of the laboratory's policy and procedure manual identified the test menu, "Chem 8+ - Sodium, Potassium, Chloride, Glucose, iCA, TCO2, BUN, Creat, Hematocrit" and Activated Clotting Time (ACT). 2. Interview with the laboratory representative, on 11-07-23 at 11:25 am, stated that patient testing started on 10-04-2021 with the i-STAT 1 system. 3. Review of laboratory records found no documentation to verify accuracy, precision, reportable range, or reference intervals for the two cartridges (Chem 8+ and ACT) in use for ten of ten analytes resulted on the i-STAT 1 system (serial number: 420912). 4. On survey date 11/7 /2023, at 11:18 am, the laboratory representative confirmed no analysis or interpretation of analytes tested were performed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following -- 3 of 7 -- occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory representative; the laboratory failed to perform calibration verification every six months as required per 493.1255 for iSTAT Chem 8+ testing in 2021 through 2023. Findings Include: 1. Upon the tour of the facility on 11-07-2023, at 11:06 am, the laboratory representative stated calibration verification materials and an external stimulator are to be ran every six months. 2. The calibration verification records for the iSTAT Chem 8+ cartridges on the i-STAT 1 system (Serial Number: 420912) identified calibration verifications were performed: 11-17-2021 08-05-2022 08-22-2022 10-31-2023 This showed a greater than six-month gap from the 11-17-2021 calibration verification to the 08-05- 2022 calibration verification and the 08-22-2022 calibration verification to the 10-31- 2023 calibration verification. 3. On an initial survey conducted on 11/07/2023 at 11: 18 am, the laboratory representative confirmed the above findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with the laboratory representative, the laboratory failed to meet the criteria for acceptability of quality control (QC) results prior to reporting patient test results as required per 493.1256 for one of seven patient testing dates reviewed for glucose testing using iSTAT Chem 8+ cartridges, affecting two patient results. Findings include: 1. Review of quality control results of seven randomly selected patient testing dates was performed (11-23-2021, 04-05-2022, 07-12-2022, 09-16-2022, 01-17-2023, 06-21-2023, and 10-18-2023). 2. One of seven testing dates (7-12-2022) showed the TriControl Level 1 for glucose using the Chem 8+ cartridge was unable to obtain a quantifiable value. "Glu ***mg /dL" 3. No evidence of repeat testing or