Laboratorio Clinico Espinosa

Summary Statement of Deficiencies D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on Immuno Card Mycoplasma manufacturer's instructions, General Immunology (Mycoplasma pneumoniae) testing record review from January 2022 to October 31, 2022 and interview with the laboratory supervisor on November 1, 2022 at 11:15 AM, it was determined that the laboratory failed to follow the manufacturer's instruction when 50 out of 50 patients specimens were tested and reported for of Mycoplasma pneumoniae from January 2022 to October 31, 2022. The findings include: 1. The laboratory use the Immuno Card Mycoplasma Test Cassette to perform the Mycoplasma pneumoniae qualitative tests. 2. The manufacturer's instruction establishes to perform the test procedures at room temperature range from 22 to 25 C. 3. On November 1, 2022 at 11:15 AM, review of the Mycoplasma pneumoniae testing records showed that the laboratory did not monitor nor document the room temperature when patient's specimens were tested for Mycoplasma by Immuno Card Meridian method from from January 2022 to October 31, 2022. 4. The laboratory supervisor confirmed on November 1, 2022 at 11:30 AM, that the laboratory did not monitor nor document the room temperature when it processed the patients specimens for Mycoplasma pneumoniae test. 5. The laboratory processed and reported 50 patient samples for Mycoplasma pneumoniae test from January 2022 to October 31, 2022. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(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 3 -- 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 routine chemistry calibration verification records review ( year 2021-2022 ), patient results work sheets and laboratory general supervisor interview , it was determined that the laboratory failed to follow manufacturer's calibration verification instructions when performed the calibration verification in year 2022. The findings include: 1. The laboratory used the Chem well T system to perform glucose and lipid panel tests. 2. Review of the routine chemistry calibration verification records showed that the procedures performed in February and August 2022 did not include a maximum value near the upper limit. ( review on November 1, 2022 at 10:52 a.m. ) 3. The Chemwell system reportable range were the following: triglycerides : 0-1000mg /dl cholesterol : 0-500 mg/dl glucose : 0-600 mg/dl hdl ( high density lipoprotein : 2- 150 mg/dl 4. On February 2022 the laboratory calibration verification results showed the following values: a. Hdl reportable range ( 2-150 mg/dl ) tested values = 30.9 and 63.2 mg/dl High point -131.2 The high point was obtained by multiply the second value of 63.2 by two ( 2 ) b. cholesterol reportable range (0-500 mg/dl ) tested values = 97 and 201 mg/dl High point -402 The high point was obtained by multiply the second value of 201 by two ( 2 ) c. triglycerides reportable range (0-1000 mg/dl ) tested values = 100 and 191 High point -400 The high point was obtained by multiply the second value by two ( 2 ) d. glucose reportable range (0-600 mg/dl ) tested values = 50 and 104 mg/dl High point -208 The high point was obtained by multiply the second value of 104 by two ( 2 ) 5. On August 2022 the laboratory calibration verification results showed the following values: a. cholesterol reportable range (0- 500 mg/dl ) tested values = 96 and 200 mg/dl High point -400 The high point was obtained by multiply the second value of 200 by two ( 2 ) c. triglycerides reportable range (0-1000 mg/dl ) tested values = 98 and 202 High point -404 The high point was obtained by multiply the second value of 202 by two ( 2 ) d. glucose reportable range (0-600 mg/dl ) tested values = 50 and 96 mg/dl High point -192 The high point was obtained by multiply the second value of 96 by two ( 2 ) 6. The General supervisor state on November 1, 2022 at 11:05 a.m. that no calibration verification external material was used to obatin the third point. 7. The laboratory patient results work sheet showed that the laboratory performed and reported the following patients results -- 2 of 3 -- and the results were over the reportable range determined by the laboratory calibration verification results : 8/11/22 415368 ( cholesterol- 232 mg/dl ) 415488 ( cholesterol - 206 mg/dl, triglycerides - 261 mg/dl ) 8/18/22 415848 ( cholesterol - 248 mg/dl ) 415998 ( cholesterol - 222 mg/dl, triglycerides - 364 mg/dl ) 415928 ( cholesterol - 244 mg/dl ) 8/25/22 416288 ( cholesterol - 220 mg/dl ) 416298 ( cholesterol - 242 mg /dl ) 416328 ( cholesterol - 234 mg/dl ) 9/1/22 416738 ( cholesterol - 272 mg/dl ) 616748 ( triglycerides - 247 mg/dl ) 416818 ( cholesterol - 258 mg/dl ) 10/20/22 419808 ( cholesterol - 232 mg/dl ) 419768 ( cholesterol - 216 mg/dl ) Review on 11/1 /2022 at 10:55 a.m. 7. The laboratory general supervisor stated on November 1, 2022 at 11:15 a.m. that the laboratory used two calibration material ( control ) and the high value was obtained multiply by 2 the mid- point value. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: 1. Based on Mycoplasma pneumonia rapid test quality control records ( year 2021- 2022 ) and interview with the laboratory general supervisor on November 1, 2022 at 11:30 AM, it was determined that the laboratory director failed to assure that the laboratory follow the manufacturer's instruction when 50 patients specimens were tested and reported for Mycoplasma pneumoniae from January 2022 to October 31, 2022. Refer to D5449. 2. Based on routine chemistry calibration verification records reviewed (years 2021-2022) and laboratory general supervisor interview on November 1, 2022 at 11:30 AM, it was determined that the laboratory director did not assure that establish calibration verification procedures were followed. Refer to D5439. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: 1. Based on routine chemistry calibration records reviewed (years 2021-2022) and laboratory general supevisor interview on November 1, 2022 at 11:30 AM, it was determined that the general supervisor did not assure that quality control procedures related to calibration and calibration verification procedures were followed. Refer to D5439. 2. Based on Mycoplasma pneumonia rapid test quality control records ( year 2021-2022 ) and interview with the laboratory general supervisor on November 1, 2022 at 11:30 AM, it was determined that the laboratory general supervisor failed to follow the manufacturer's instruction when 50 patients specimens were tested and reported for Mycoplasma pneumoniae from January 2022 to October 31, 2022. Refer to D5449. -- 3 of 3 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on the monthly preventive maintenance of the Chem Well system record (years 2017 and 2018) review, lack of the Chem Well printouts for the alignments procedures and filter voltage checks and laboratory general supervisor interview on November 16, 2018 at 9:35 AM, it was determined that the laboratory did not retain printouts of the Chem Well system to demonstrate that the monthly preventive maintenance (the alignments procedures and filter voltage checks) were performed from February 2017 to August 2017 and from October 2018 to September 2018. The findings include: 1. The laboratory processed the glucose test and the lipid profile by the Chem Well system. 2. On November 16, 2018 at 9:35 AM, the preventive maintenance of the Chem Well system record showed that the laboratory did not retained the printouts of the Chem Well system for the the monthly preventive maintenance (the alignments procedures and filter voltage checks) from February 2017 to August 2017 and from October 2018 to September 2018. 3. The general supervisor confirmed November 16, 2018 at 9:35 AM, that the laboratory did not retained the printouts of those preventive maintenance. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, 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 -- and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on the monthly preventive maintenance of the Chem Well system record (years 2017 and 2018) review, lack of the Chem Well printouts for the alignments procedures and filter voltage checks and laboratory general supervisor interview on November 16, 2018 at 9:35 AM, it was determined that the laboratory director failed to comply with the laboratory records retention requirements. Refer D 3031. (The laboratory did not retain printouts of the Chem Well system to demonstrate that the monthly preventive maintenance (the alignments procedures and filter voltage checks) were performed from February 2017 to August 2017 and from October 2018 to September 2018). D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on personnel competence records (years 2017 and 2018) review and interview with the laboratory supervisor on November 16, 2018 at 12:10 PM, it was determined that the laboratory director failed to establish and follow a protocol to ensure the annual competency evaluations of the following positions in the laboratory since January 2017: general supervisor, technical supervisor and technical consultant. The findings include: 1. On November 16, 2018 at 12:10 PM, the personnel competence records showed that the laboratory director did not evaluate since January 2018, the annual competence of the testing personnel who also fill the followings positions in the laboratory: general supervisor, technical supervisor and technical consultant. The laboratory director evaluated the competence of this personnel for the testing personnel responsibilities. 2. The laboratory supervisor confirmed on November 16, 2018 at 12:10 PM, that the laboratory director did not evaluated her for the responsibilities as general supervisor, technical supervisor and technical consultant. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether -- 2 of 3 -- supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel records files and interview with the laboratory supervisor on November 16, 2018 at 12:10 PM, it was determined that the laboratory director did not specify the duties of the laboratory general supervisor and technical supervisor. The finding includes: 1. On November 16, 2018 at 12:10 PM, the general supervisor personnel files showed on November 16, 2018 at 12:10 PM, that the laboratory director did not specify on writing her duties and responsibilities as technical supervisor and technical consultant. 2. The general supervisor confirmed on November 16, 2018 at 12:10 PM, that her personnel file did not includes the require information. -- 3 of 3 --