Commonwealth Health Center - Respiratory

Summary Statement of Deficiencies D0000 A federal surveyor from the Centers for Medicare & Medicaid Services (CMS) Survey Branch conducted a recertification survey, the following standard level deficiency was cited: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: I. Based on review of manufacturer's instructions, laboratory environmental records, and interview with the laboratory manager, the laboratory failed to define,monitor and document the room humidity level where 2 of 2 Siemens Rapid Point 500e analyzers were in use as evidenced by: 1. In review of the manufacturer's instructions in Appendix E: Specification for the Siemens Rapid Point 500e analyzers states, "Ambient operating relative humidity 5-85% noncondensing." 2. In review of the laboratory environmental records, the laboratory could not provide documentation that they recording and documenting the manufacturer's requirement of humidity for the two Rapid point 500e Analyzers used in the laboratory. 3. In interview with the laboratory manager at 1535 he confirmed that they didn't record and document the humidity. II. Based on direct observation, laboratory temperature charts, and interview with the laboratory manager, the laboratory failed to define room temperature ranges Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- consistent with the manufacturer's instructions for one of one reagent stored in the laboratory as evidenced by: 1. In direct observation at 1525 the following reagent was stored in the laboratory at room temperature with storage requirements of 4-25 degrees C. a. 1 case of Multicap-S pH blood gas 175ul Lot #2811234N expiration date of 2026-11-30 2. In review of the laboratory's temperature chart called "Daily Temperature Check," their temperature range was set at 20-30 degree C. 3. In an interview at 1526 with the laboratory manager, he confirmed that the temperature ranges differ from the manufacturer's instructions and that they would not have take

Summary Statement of Deficiencies 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 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 laboratory director and laboratory personnel interviews and calibration verification record review on April 27, 2023 at 10:20 am, at least once every 6 months, the laboratory failed to perform calibration verification procedures on its two blood gas instruments. Findings included: a. It was the practice of the laboratory to perform patient blood gas tests on one of two Opti CCA instruments. b. The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory director and laboratory personnel confirmed that the laboratory had not been performing calibration verification procedures on the two blood gas instruments. b. According to survey documents, the laboratory performed approximately 3,000 patient blood gas tests annually. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on laboratory director and laboratory personnel interviews and laboratory written policies and procedures record review on April 27, 2023 at 10:10 am, the laboratory, which performs the same blood gas tests using two different instruments, failed to have written policies and procedures that detail the laboratory's system that at least twice a year evaluates and defines the relationship between test results using the different instruments. Findings included: a. It was the practice of the laboratory to perform patient blood gas tests on one of two Opti CCA blood gas instruments. b. At least twice a year and often more frequently, the laboratory tested the same sample on each of the two instruments and compared the blood gas test results. However, the laboratory maintained no written policy and procedure describing this protocol and what the laboratory considered an acceptable comparison. c. According to survey documents, the laboratory performed approximately 3,000 patient blood gas tests annually. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved