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: Through observation, review of temperature records, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature of one of two rooms in which supplies with storage temperature requirements were stored on each day of operation. Findings follow: A) During a tour of the laboratory on 6/29/22 at 11:30 AM two rooms containing items with a temperature storage requirement , the main laboratory and a separate phlebotomy area separated from the main laboratory by a closable door, were observed. B) During a review of the laboratory's temperature records it was noted that temperature records for only the main laboratory were presented. C) During a tour of the laboratory on 6/29/22 at 03: 55 pm, 10 Vacuette blue top blood collection tubes, lot # A21083A3, expiration date 2022-08-01; 20 BD Serum Separator blood collection tubes , lot# 1333110, expiration date 2022-11-30; 10 Vacuette lavendar top tubes, lot# B21093UY expiration date 2023-01-10, all with a storage temperature range of 4 degrees C to 25 degrees C., were observed in the phlebotomy room. D) Upon request, the laboratory could not present the temperature records for the phlebotomy room in which the supplies identified above were stored,. E) In an interview on 6/29/22 at 03:55 pm 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 3 -- laboratory staff member, identified as number three on the CMS 209 form, stated that the daily temperature of the phlebotomy room in which the supplies, identified above, were stored had not been monitored and recorded.. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Through a review of personnel files for four of four laboratory testing personnel listed on the CMS 209 form, through a lack of documentation, and through interviews with staff, it was determined that one of four laboratory testing personnel failed to meet qualification requirements as testing personnel as evidenced by: D6065 - one of four laboratory testing personnel lacked documentation of appropriate education to qualify as a testing personnel D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Through a review of laboratory personnel records for four testing personnel, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to document that laboratory employee one of four testing personnel (#6 as listed on the CMS 209 form) met educational requirements to perform moderate complexity testing. Survey findings follow: A. In an interview, at 12:20 p.m. on 6/29/22, employee #2 (as listed on the CMS 209 form) confirmed employee #6 performs Complete Blood Cell testing on the moderately complex Sysmex hematology system. B. Review of the personnel files for the testing personnel, identified as number 6 on the CMS 209 form, revealed that the employee began employment in December 2020. The only educational documentation was a certificate issued by the "Republika ng Pilipinas" which the surveyor was unable to interpret C. In the interview, at 12:20 p. m. on 6/29/22, laboratory employee, identified as #3 on the CMS 209 form, stated that she did not know what the educational certificate indicated, and there was no documentation of the educational equivalency evaluation present. She further stated that the testing person, identified as number 6 on the CMS 209 form, had transferred from the related hospital and perhaps the hospital human resources department had -- 2 of 3 -- the educational equivalency evaluation which would qualify employee , identified as number 6 on the CMS 209 form, as a moderate complexity testing personnel. D. An email on 7/7/22 at 02:42 pm.from a hospital employee, identified on a separate personnel identification form, stated that the hospital policy was that it was the responsibility of individual employees to provide the educational equivalency evaluations, when required, and in the case of the testing personnel, identified as number 6 on the CMS 209 form, this was overlooked and was currently being pursued. -- 3 of 3 --