Summary:
Summary Statement of Deficiencies 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 laboratory procedure manual review, laboratory record review and testing personnel interview, it was determined that the laboratory failed to document acceptable refrigerator readings for 9 of 36 months reviewed from September 2017 through September 2019 (2017: October and September; 2018: January, March, July, October, November, and 2019: January and March) Findings include: 1. Review of the laboratory procedure manual on 09/10/19 revealed that the laboratory rerigerator should remain between 36 to 46 degrees Fahrenheit. 2. Review of the laboratory temperature recordings on 09/10/19 revealed that the laboratory's refrigerator temperatures were below 36 degrees Fahrenheit for the following months: a. October 2017: 8 days b. September 2017: 1 day c. January 2018: 3 days d. March 2018: 5 days e. July 2018: 10 days f. October 2018: 11 days g. November 2018: 2 days h. January 2019: 4 days i. March 2019: 2 days 3. Testing personnel confirmed during an onsite interview on 09/10/2019 at 2:00pm that the laboratory had failed to failed to document acceptable refrigerator readings for 9 of 36 months reviewed from September 2017 through September 2019 (2017: October and September; 2018: January, March, July, October, November, and 2019: January and March). D6054 TECHNICAL CONSULTANT RESPONSIBILITIES 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 -- CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on the CMS 209 review, lack of documentation and testing personnel interview, the laboratory failed to ensure that testing personnel were evaluated annually after the first year of testing patient specimens for 2 of 7 testing personnel (employees 1and 4 on CMS 209) for one of two years reviewed (2017) . Findings include: 1. The laboratory listed 7 testing personnel on the CMS-209 on the day of the survey. 2. Documentation review on 09/10/19 revealed that an annual training and evaluation was unavailable for review on the day of the survey for 2 of 7 testing personnel (employees 1 and 4 on CMS 209) for one of two years reviewed (2017) . 3. Testing personnel confirmed during an onsite interview on 09/10/19 at 2:00pm that the laboratory had failed to ensure that testing personnel were evaluated at least annually after the first year of testing patient specimens. -- 2 of 2 --