Summary:
Summary Statement of Deficiencies D0000 A survey for recertification was performed March 19-20, 2019. The laboratory was in compliance with the CLIA regulations and recertification is recommended. Based on review of laboratory records, the laboratory had not performed any tests for histopathology since the previous survey cycle and therefore, the speciality of histopathology could not be certified. The CMS-116 will be updated to remove the speciality of histopathology. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: 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 storage of laboratory reagents. The findings were: 1. Surveyor observation made in the microbiology section on March 19, 2019 at 11:00 hours revealed the laboratory's fungal stain reagent, Chlorazol Black E, (lot number K19142) was stored on the bench top by the sink. 2. Review of the manufacturer's instructions located on the label of the container stated, "Store in a dark place." 3. Interview with testing personnel six (as listed on Form CMS-116) on March 19, 2019 at 11:05 hours in the laboratory confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 surveyor observation, review of manufacturer's instructions, and confirmed in interview of facility personnel, the laboratory failed to monitor the temperature of the environment where laboratory supplies were located. The findings were: 1. Surveyor observation made on March 20, 2019 at 16:00 hours at the Nurse's Station revealed no means to monitor the temperature of the environment. 2. Review of supplies located at the Nurse's Station revealed the following items: Modified Amies Swabs Lot 7J18A 6 swabs Copan Transport System Lot 180015000 2 swabs 3. Review of the manufacturer's instructions for Modified Amies Swabs located on package labeling revealed the items were to be stored at, "4-25 degrees Celsius or 40- 77 degrees Fahrenheit." 4. Review of the manufacturer's instructions for Copan Transport System located on package labeling revealed the items were to be stored at, "5-25 degrees Celsius." 5. Interview with the technical consultant on March 20, 2019 at 16:03 hours at the Nurse's Station confirmed the findings. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation and confirmed in interview of facility personnel, the laboratory failed to ensure laboratory reagents were labeled with contents and expiration dates. The findings were: 1. Surveyor observation made in the laboratory on March 19, 2019 at 09:50 hours revealed a bottle of reagent not labeled with the identification of the contents or the expiration date. 2. Surveyor observation made in the microbiology section on March 20, 2019 at 11:08 hours revealed a bottle of reagent not labeled with the identificaton of the contents or the expiration date. 3. Interview with the technical consultant on March 20, 2019 at 11:30 hours confirmed the findings. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory MNPT records, review of patient results, and confirmed in interview of facility personnel, the laboratory failed to enter the geometric mean into the Instrumentation Laboratory ACL TOP 350 coagulation analyzer. The findings were: 1. Surveyor observation made on March 20, 2019 at 08: 00 hours in the laboratory revealed the geometric mean entered into the ACL TOP 350 was 10.3. 2. Review of the current lot number for MNPT records revealed RecombiPlastin 2G reagent was approved for use on December 19, 2018. The lot number for the RecombiPlastin 2G reagent was N0588147 with an expiration date of May 31, 2020. 3. Review of the calculations for the current MNPT studies revealed the actual geometric mean wa 10.6. The incorrect geometric mean was entered into the ACL TOP 350 analyzer. 4. Review of patient results from January 1, 2019 to March 20, 2019 revealed the following patients were performed with the incorrect geometric mean was used (see patient alias list). 5. Interview with the technical consultant on March 20, 2019 at 09:00 hours in the laboratory confirmed the findings. After he recalculated the geometric mean, he agreed that the actual geometric mean was 10.6 not 10.3. Key: MNPT - mean normal prothrombin time D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of